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208 Study Matches

Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA

Radiation, Stereotactic Body Radiation Therapy.
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Assal Rahimi
115315
Female
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT02685332
STU 062015-085
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Inclusion Criteria:

• Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies
• Willing and able to provide consent
• Age >=18 years.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
• Surgical treatment of the breast with lumpectomy Clinical Target Volume (CTV) margin up to 5 cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions). Re-excision of surgical margins is permitted.
• Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less)
• Patients with invasive disease are required to have axillary staging including: sentinel node biopsy alone if sentinel node is negative, sentinel node biopsy followed by axillary dissection with a minimum of 6 axillary nodes sampled if sentinel node is positive, or axillary dissection alone (with a minimum of 6 axillary nodes). Patients with DCIS are not required to have axillary staging.
• Patients with a history of non-breast invasive malignancies are eligible if they have been disease-free for 3 or more years prior to entry into the study
Exclusion Criteria:

• T2 (>3.0 cm), T3, stage III, or stage IV breast cancer
• More than 3 histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension.
• Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor.
• Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
• Non epithelial breast malignancies such as sarcoma or lymphoma.
• Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters.
• Synchronous bilateral invasive or non-invasive breast cancer.
• Paget's disease of the nipple.
• Previous breast radiation on ipsilateral side or thoracic radiation on the ipsilateral side.
• Treatment plan that includes regional nodal irradiation.
• Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed breast cancer prior to registration. Endocrine therapy may be given but not within 28 days prior to study entry and must be stopped if the patient will be receiving chemotherapy until completion of chemotherapy. Patients must discontinue any hormonal agents such as raloxifene, tamoxifen, or other selective estrogen receptor modulators prior to registration.
• Patients with collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
• Pregnancy or lactation at the time of registration. For women of childbearing age, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.
• Patients with severe co-extensive comorbidities or significant psychiatric illness.
Radiation: Stereotactic Radiation
Early Stage Breast Cancer
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Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant

This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.
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Madhuri Vusirikala
84755
All
18 Years to 65 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT01744223
STU 042013-067
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Inclusion Criteria:

• Lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
• HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl, and loci. A minimum match of 5/10 is required. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
• Subjects with adequate physical function as measured by:a)Cardiac: Left ventricular ejection fraction at rest must be >35%, or shortening fraction > 25%. b)Hepatic: Bilirubin < 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase < 5 x ULN. c)Renal: Serum creatinine within normal range for age, or creatinine clearance or GFR > 40 mL/min/1.73m2. d)Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); or 02 saturation > 92% on room air.
• Clinical Diagnosis of one of the following: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma
• Subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
• Performance status: Karnofsky/Lansky score > 60%.
Exclusion Criteria:

• HLA-matched, related or 7-or 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) unrelated donor able to donate.
• Autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
• Pregnancy or breast-feeding.
• Evidence of HIV infection or known HIV positive serology.
• Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
• Non-hematologic malignancy within prior three (3) years.
• Prior allogeneic hematopoietic stem cell transplant.
• Subjects with a history of primary idiopathic myelofibrosis.
• Bovine product allergy.
Biological: BPX-501 and AP1903
Lymphoma, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia
iCaspase9, iCasp9, Inducible Caspase, AP1903, Dimerizer drug, T depleted, Suicide gene, CD-34 selection, haplotransplantation, Graft versus host disease, Allogenic transplantation
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Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
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Muhammad Beg
125541
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02562755
STU 102015-040
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Inclusion Criteria:

• Histological/cytological diagnosis of primary HCC
• Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
• At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
• Child-Pugh Class A
• Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Adequate hematological, hepatic, and renal function:
• Additional inclusion criteria exist
Exclusion Criteria:

• Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
• Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
• Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
• History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
• Bulky disease patients
•tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
• Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
• Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
• History of severe eczema (as determined by the Investigator) requiring medical treatment
• Additional exclusion criteria exist
Biological: Pexastimogene Devacirepvec (Pexa Vec), Drug: Sorafenib
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma (HCC), Pexastimogene Devacirepvec (Pexa-Vec), Sorafenib, GM-CSF therapy, Thymidine Kinase-Deactivated Vaccinia Virus, Oncology, Recombinant Vaccinia Virus, Oncolytic Virus Therapy, Oncolytic virotherapy
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Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis. PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.
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Robert Timmerman
69821
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT00855803
STU 072010-134
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Eligibility: Inclusion:
• Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
• Patients must have a VAS of ≥4 at any of the planned treatment sites
• Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
• Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
• Narcotic pain prescription and usage information must be available and documented
• Patients must sign study specific consent
• Above the age of 18
• For women of childbearing age a negative pregnancy test is required
• Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
• Zubrod score of 0-2 Exclusion:
• Patients who have been non-ambulatory for more than 7 days
• Patients with compression fractures
• Spine instability requiring fixation
• Patients with paraspinal extension
• Patients with bony fragments
• Planned systemic treatment within one week after treatment.
• Absence of pathological diagnosis of cancer
• Chemotherapy within one week of treatment
• Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
• Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Patient had a transmural myocardial infarction within the last 6 months
• Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
• PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
• Platelet count is < 50,000
• History of significant psychiatric illness Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring
Radiation: radiation
Unspecified Adult Solid Tumor, Protocol Specific, Metastatic Cancer, Pain
spinal cord metastases, unspecified adult solid tumor, protocol specific, pain
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HIFU Hyperthermia With Liposomal Doxorubicin (DOXIL) for Relapsed or Refractory Pediatric and Young Adult Solid Tumors

The purpose of this study is to determine whether Doxil (liposomal doxorubicin) given prior to MR-HIFU Hyperthermia is safe for the treatment of pediatric and young adult patients with recurrent and refractory solid tumors.
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Theodore Laetsch
148176
All
1 Year to 40 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT02557854
STU 042015-047
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Inclusion Criteria:

• Age 1-40 years
• Histologically confirmed malignant extra-cranial solid tumor or demoid fibromatosis
• The subject's tumor must have relapsed after or failed to respond to frontline therapy and there must be no other known curative therapies available. Patients with desmoid fibromatosis must have relapsed after or failed to respond to at least one prior line of therapy, and in the opinion of the treating physician surgical resection of the tumor must not be possible without an amputation or other surgery predicted to result in an unacceptable functional deficit.
• Subject must have a life expectancy of > 8 weeks
• Karnofsky performance status > 50% for patients >16 years of age, or Lansky performance status > 50% for patients < 16 years of age.
• The subject must have at least 1 measurable target lesion >10mm in longest dimension that is in an anatomic location treatable by MR-HIFU. Note that for this study, lesions in bone WILL be considered measurable provided they meet the other criteria by RECIST and are confirmed to be metabolically active on baseline studies by either MIBG uptake (for neuroblastomas) or PET avidity. Target lesions should be located so that they can be adequately heated by a hyperthermia treatment cell with a diameter of up to 58 mm, centered at a depth of 35 to 80 mm from the skin. There should be no staples, implants, extensive scarring, or other highly ultrasound absorbing or reflecting tissue in the expected beam path. For the first 5 patients enrolled on this study only, the lesion must be located in the extremities or pelvis to be considered treatable by MR-HIFU.
• The subject must have recovered from the acute toxic effects of all prior therapy with the exception of alopecia. The following time must have elapsed from the last dose of the following medications to study enrollment:
• myelosuppressive chemotherapy 14 days
• hematopoetic growth factors 7 days (14 days for Neulasta)
• biologic agent 7 days
• monoclonal antibody 3 half-lives
• immunotherapy (ie tumor vaccines) 42 days
• palliative small port XRT 14 days
• substantial bone marrow XRT 6 weeks
• stem cell transplant or infusion without TBI 12 weeks
• total body irradiation (TBI) 24 weeks
• Adequate organ and marrow function as defined below:
• absolute neutrophil count ≥ 1,000/mcL
• platelets ≥ 75,000/mcl (without transfusion for 7 days)
• hemoglobin > 8g/dL (may receive transfusions)
• total bilirubin < 1.5 mg/dL
• ALT(SPGT) < 225 U/L (45 U/L defined as ULN)
• creatinine clearance or radioisotope GFR > 70 mL/min/1.73m2 OR a serum creatinine (mg/dL) less than or equal to the following:
• Age (yrs)-----Male (mg/dL)-----Female (mg/dL)
• 1-1.99----------0.6------------------0.6
• 2-5.99----------0.8------------------0.8
• 6-9.99----------1--------------------1
• 10-12.99------1.2------------------1.2
• 13-15.99------1.5------------------1.4
• >16-------------1.7------------------1.4
• Adequate cardiac function defined as an ejection fraction > 50% or shortening fraction > 27%
• Cumulative lifetime anthracycline dose of < 450mg/m2
• Females and males of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A male of child-bearing potential is any male (regardless of sexual orientation, having undergone a vasectomy, or remaining celibate by choice) who has attained Tanner stage III or greater sexual development. A female of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has undergone menarche OR is > 13 years of age
• Females of child-bearing potential must have a negative serum pregnancy test within 7 days of treatment.
• Signed written informed consent must be obtained prior to any study procedures.
Exclusion Criteria:

• Subjects may not be receiving any other investigational agents or anticancer therapies.
• Subjects with known active brain metastases will be excluded from this clinical trial. Patients with brain metastases that have been treated and stable for > 30 days following treatment will be eligible.
• Subjects who have received prior Doxil and progressed on this therapy are not eligible, but subjects may have received prior doxorubicin.
• Subjects with a history of tumor progression within 30 days of anthracycline administration are not eligible. However, subjects who have previously received an anthracycline and subsequently relapse greater than 30 days after their most recent prior dose of anthracycline will be eligible.
• History of allergic reactions attributed to doxorubicin or Doxil
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Subjects with a contraindication to MR-HIFU
• Subjects with conditions that carry high anesthetic risk in the opinion of the treating anesthesiologist are not eligible (i.e. subjects with significant airway compression by tumor or craniofacial abnormalities)
Drug: Doxorubicin HCl liposomal injection, Device: Philips Sonalleve MR-HIFU Hyperthermia
Neuroblastoma, Sarcoma, Rhabdomyosarcoma, Sarcoma, Ewing, Osteosarcoma, Desmoid
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Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer

This study is being done because there are currently no approved and no commonly working targeted therapies in anaplastic thyroid cancer (ATC). This is an area of urgent need for patients, not just for approved treatments but also rationally-designed clinical trials designed specifically for ATC. Patients diagnosed with anaplastic thyroid cancer have a very high likelihood of dying because of their disease. As such there is a clear need for improving therapy for ATC.
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Saad Khan
136971
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02688608
STU 012016-019
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Inclusion Criteria:
1. Be willing and able to provide written informed consent for the trial. 2. Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer. A diagnosis of possible ATC/UTC will be allowed if the clinical presentation is consistent with anaplastic or undifferentiated thyroid cancer. 3. Be ≥ 18 years of age on day of signing informed consent. 4. Have measurable disease based on RECIST 1.1. 5. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived sample. 6. Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 7. Demonstrate adequate organ function as defined in the protocol. , 8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. 10. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has a known history of active TB (Bacillus Tuberculosis). 4. Hypersensitivity to pembrolizumab or any of its excipients. 5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. Has known history of, or any evidence of active, non-infectious pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 18. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Drug: Pembrolizumab
Anaplastic Thyroid Cancer
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Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma

Nivolumab (brand name Opdivo): IV, 3 mg/kg q2 weeks, until disease progression or unacceptable toxicity; SABR, dose variable, in 1-3 fractions.
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Raquibul Hannan
125338
All
18 Years to 100 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02781506
STU 122015-052
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Inclusion Criteria:

• At least 18 years of age
• Willing and able to provide consent
• Pathologic diagnosis of metastatic RCC with clear cell component
• Measurable disease in at least 2 non-radiated sites. Progression or intolerance to at least one prior systemic anti-angiogenic therapy.
• Eligible for extra-CNS SAbR to 1-6 sites of disease
• Must have received at least one prior anti-angiogenic therapy in the advanced or metastatic setting. Prior cytokine therapy (eg, IL-2, IFN-α), vaccine therapy, or treatment with cytotoxic therapy is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• Previous treatment with surgery, radiation, chemotherapy, targeted agents (see above) are allowed provided that: Chemotherapy/Major surgery was administered > 14 days before the start Nivolumab; Minor surgery, radiation, or any targeted agents were administered > 7 days before the start of Nivolumab
• Performance status ECOG 0, 1, 2 or 3.
• Adequate organ and marrow function as defined below (obtained within 14 days of first dose of drug):
• leukocytes≥ 2,000/mcL
• absolute neutrophil count ≥ 1,500/mcL
• platelets ≥ 50,000/mcl
• total bilirubin ≤ 2mg/dL
• AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal
• Women of child-bearing potential
• female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product.
• Women must not be breastfeeding.
• must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half lives.
• Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half lives. This is equivalent to 31 weeks after discontinuation of Nivolumab.
• Adequate Renal function with Cr ≤ 2.5 mg/dL.
Exclusion Criteria:

• Subjects who have had major surgery (such as nephrectomy) or chemotherapy within 2 weeks prior to first dose of drug
• Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
• Uncontrolled adrenal insufficiency or active chronic liver disease
• Any history of CNS metastases that is not adequately treated with surgery or SABR >14 days prior.
• Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• Any positive history for HIV/AIDS, HTLV, hepatitis B or hepatitis C virus indicating acute or chronic infection.
• Any active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
• Subjects with life expectancy < 6 months
• Subjects receiving any other investigational or standard antineoplastic agents.
• Prior malignancies active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast?, or etc.
• Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
• Patients with history of hypersensitivity to monoclonal antibodies
• Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Drug: Nivolumab, Radiation: SAbR
Metastatic Clear Cell Renal Cell Carcinoma
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p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.
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David Miller
14954
Female
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02098343
STU 092016-030
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Inclusion Criteria:

• Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
• Disease Progression between 6-24 months after a first or second platinum based regimen
• At least a single measurable lesion. Phase II patients only
• Adequate organ function prior to registration
• Toxicities from previous cancer therapies must have recovered to grade 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE] 4.0) Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
• ECOG performance status of 0 to 1
Exclusion Criteria:

• Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
• History of allergic reactions to carboplatin, platinum containing compounds or mannitol and/or hypersensitivity to PLD or to any of the excipients
• Unable to undergo imaging by either CT scan or MRI
• Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
• Is taking concurrent (or within 4 week prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed
Drug: APR-246, Drug: Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53
Ovarian cancer, Ovarian carcinoma, High Grade Serous Ovarian Cancer, Recurrent Cancer, Resistant Cancer
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Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Daniel Bowers
10760
All
3 Years to 21 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT00392327
STU 122010-132
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Inclusion Criteria:

• Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor
• As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued
• All patients with M4 disease are not eligible
• A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility
• Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory
• Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred
• Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively
• Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks
• No previous chemotherapy or radiation therapy
• Patients taking Accutane (isotretinoin) for acne must discontinue drug use with this indication prior to enrollment; corticosteroids should not be used during chemotherapy administration as an antiemetic
• Isotretinoin is contraindicated in patients with parabens allergy and patients with soybean allergy; concurrent use with tetracyclines should be avoided; intake of vitamin A should be limited for the duration of isotretinoin treatment
• Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (cytochrome P450 3A4) include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort; the use of these drugs should be avoided with vincristine (vincristine sulfate)
• CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy
• Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity
• Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin
• No other experimental therapy is permitted while on study
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:
• 0.4 mg/dL (1 month to < 6 months of age)
• 0.5 mg/dL (6 months to < 1 year of age)
• 0.6 mg/dL (1 to < 2 years of age)
• 0.8 mg/dL (2 to < 6 years of age)
• 1.0 mg/dL (6 to < 10 years of age)
• 1.2 mg/dL (10 to < 13 years of age)
• 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
• 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
• Total bilirubin < 1.5 x upper limit of normal (ULN) for age
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT (AST) or SGPT (ALT) must be < 5 x ULN
• Absolute neutrophil count (ANC) >= 1,000/uL
• Platelets >= 100,000/uL (untransfused)
• Hemoglobin >= 8 g/dl (may be transfused)
• Female patients who are post-menarchal must have a negative pregnancy test; lactating female patients must agree not to breast-feed while on this trial; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Radiation: Radiation Therapy, Drug: Vincristine Sulfate, Drug: Carboplatin, Drug: Cisplatin, Drug: Cyclophosphamide, Biological: Filgrastim, Drug: Isotretinoin, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment
Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor, Untreated Childhood Medulloblastoma, Untreated Childhood Pineoblastoma
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Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB or Stage IIIB-IVB Hodgkin Lymphoma

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin lymphoma.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Martha Pacheco
42311
All
2 Years to 22 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02166463
STU 042015-028
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Inclusion Criteria:

• Patients with newly diagnosed, pathologically confirmed cHL meeting one of the following Ann Arbor stages are eligible:
• Stage IIB with bulk
• Stage IIIB
• Stage IVA
• Stage IVB
• If study eligibility by staging is uncertain, consultation with Imaging and Radiation Oncology Core (IROC) Rhode Island (RI) may be obtained prior to study enrollment
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• 2 to < 6 years: male 0.8 mg/dL, female 0.8 mg/dL
• 6 to < 10 years: male 1 mg/dL, female 1 mg/dL
• 10 to < 13 years: male 1.2 mg/dL, female 1.2 mg/dL
• 13 to < 16 years: male 1.5 mg/dL, female 1.4 mg/dL
• >= 16 years: male 1.7 mg/dL, female 1.4 mg/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine transaminase [ALT]) < 2.5 x upper limit of normal (ULN) for age
• Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
• Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin lymphoma (HL)
• For children who are unable to cooperate for PFTs, the criteria are: no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry reading of > 92% on room air
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with nodular lymphocyte-predominant HL
• Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
• Patients who are pregnant; (a negative pregnancy test is required for female patients of childbearing potential)
• Lactating females who plan to breastfeed
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 30 days after the last dose of chemotherapy
• Patients known to be positive for human immunodeficiency virus (HIV) are not eligible
• Patients who have received any previous chemotherapy or radiation therapy are not eligible
• Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified, are not eligible
Biological: Bleomycin Sulfate, Drug: Brentuximab Vedotin, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Drug: Etoposide, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: Prednisone, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Vincristine Sulfate
Childhood Hodgkin Lymphoma, Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma, Classic Hodgkin Lymphoma
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Phase 2 Study of MLN0128, Combination of MLN0128 With MLN1117, Paclitaxel and Combination of MLN0128 With Paclitaxel in Women With Endometrial Cancer

The primary purpose of this study is to determine if MLN0128 in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
David Miller
14954
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02725268
STU 042016-027
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Inclusion Criteria:
1. Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma). 2. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments. 3. At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen. 4. Measureable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be greater than or equal to (>=) 10 millimeter (mm) in long axis when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI. 5. Tumor accessible and participant consents to undergo fresh tumor biopsies. 6. Female participants 18 years or older. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 8. Female participants who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [example, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc.]) after the last dose of study drug, OR
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) 9. Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:
• Bone marrow reserve consistent with absolute neutrophil count (ANC) >= 1500 per micro liter (/mcL); platelet count >= 100,000/mcL; hemoglobin A1c (HbA1c) less than (<) 6.5 percent (%).
• Total bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be <= 2.5 * the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in liver.
• Creatinine clearance >= 50 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.
• Fasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL. 10. Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling. 11. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Exclusion Criteria:
1. Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breastfeeding are not eligible. 2. Previous treatment with any weekly taxane regimen. 3. History of severe hypersensitivity reactions to paclitaxel or any of its excipients. 4. Previous treatment with phosphoinositide 3-kinase (PI3K), serine/threonine-specific protein kinase (AKT), dual PI3K/ mammalian (or mechanistic) target of rapamycin (mTOR) inhibitors, target of rapamycin complex 1/2 (TORC1/2) inhibitors or TORC1 inhibitors. 5. Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (participants already receiving erythropoietin on a chronic basis for >=4 weeks are eligible). 6. Participants who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug. 7. A prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder. 8. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. 9. Sensory or motor neuropathy >= Grade 2. 10. Central nervous system (CNS) metastasis, endometrial leiomyosarcoma, or endometrial stromal sarcoma. 11. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or for some other reason that may alter the absorption of MLN0128 or MLN1117. In addition, participants with enteric stomata are also excluded. 12. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection, or any other condition that could compromise participation of the participant in the study. 13. Known human immunodeficiency virus infection. 14. History of any of the following within the last 6 months before administration of the first dose of study drug:
• Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures.
• Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures.
• Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia).
• Placement of a pacemaker for control of rhythm.
• New York Heart Association Class III or IV heart failure.
• Pulmonary embolism. 15. Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including:
• Uncontrolled hypertension (that is, either systolic blood pressure > 180 millimeter of mercury [mm Hg] or diastolic blood pressure > 95 mm Hg).
• Pulmonary hypertension.
• Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air.
• Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement.
• Medically significant (symptomatic) bradycardia.
• History of arrhythmia requiring an implantable cardiac defibrillator.
• Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval > 480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes). 16. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 17. Participants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated.
Drug: Paclitaxel, Drug: MLN0128, Drug: MLN1117
Endometrial Neoplasms
Drug Therapy
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Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as denosumab, may block tumor growth in different ways by targeting certain cells.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Theodore Laetsch
148176
All
11 Years to 49 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02470091
STU 112015-037
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Inclusion Criteria:

• Female patients must have a bone age of equal to or greater than 12 years of age as determined by local read of appropriate radiographic imaging
• Male patients must have a bone age of equal to or greater than 14 years of age as determined by local read of appropriate radiographic imaging
• Patients must have relapsed or become refractory to conventional therapy, with a regimen including some combination of high dose methotrexate, doxorubicin, cisplatin, ifosfamide and etoposide; and have had histologic verification of osteosarcoma at original diagnosis or at the time of recurrence
• Cohort 1 patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
• Note: Patients in Cohort 1 will be stratified as follows:
• Stratum 1: Patients >= 11 years of age but < 18 years
• Stratum 2: Patients >= 11 years of age but < 50 years
• Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
• Patients will only be eligible after they have undergone complete surgical resection of suspected metastatic disease that is histopathologically confirmed to be osteosarcoma prior to enrollment
• Note: The definition of complete resections is: gross resection of all disease as per the operating surgeon; post-operative imaging is not required for confirmation of complete resection
• Patients must undergo resection of any lung lesion meeting criteria for likely metastatic disease, defined as:
• 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm
• Patients with lung as the only site of resected metastatic disease must have refused participation in protocol AOST1421
• Patient must have adequate tumor specimen available for submission
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• Age: 11 to < 13 years old; 1.2 (male, female) maximum serum creatinine (mg/dL)
• Age: 13 to < 16 years old; 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)
• Age: >= 16 years old; 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age
• Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
• Patients who are receiving other cancer directed therapy at the time of enrollment
• Patients who have previously received denosumab
• Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium
• Patients receiving bisphosphonates
• Pre-existing conditions
• Disorders associated with abnormal bone metabolism
• Hypocalcemia that is not corrected with oral calcium supplementation
• Vitamin D < 20 ng/mL
• Paget's disease
• Prior history or current evidence of osteonecrosis of the jaw
• Any dental or oral condition likely to result in disruption of mucosal integrity during denosumab therapy including: active dental or jaw condition requiring oral surgery or tooth extraction; non-healed dental or oral surgery
• Unstable systemic disease, excluding osteosarcoma, such as unstable proximal renal tubule dysfunction (Fanconi Syndrome) or congestive heart failure
• Pregnancy and breast feeding
• Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
• Lactating females who plan to breastfeed their infants
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 5 months after the end of study treatment
Biological: Denosumab, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study
Recurrent Osteosarcoma, Metastatic Osteosarcoma, Childhood Osteosarcoma
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Phase 1 Study of MM-398 Plus Cyclophosphamide in Pediatric Solid Tumors

This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Patrick Leavey
35610
All
12 Months to 20 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT02013336
STU 092013-007
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Inclusion Criteria:

• Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma
• Disease progression after prior therapy in locally advanced or metastatic setting
• Measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria
• Age 12 months to <21 years
• Adequate bone marrow reserves, hepatic function, and renal function
• Recovered from effects of any prior surgery or cancer therapy
• Patients 18 years or older will provide written consent. A parent or legal guardian of a patient <18 years of age will provide informed consent and patients 11 to 18 years of age will provide written assent or as per participating institutional policy.
Exclusion Criteria:

• Clinically significant gastrointestinal disorders
• NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
• Active infection or unexplained fever
• Known hypersensitivity to any of the components of MM-398 or other liposomal products
• Recent Investigational therapy
• Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment
Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma, Recurrent or Refractory Solid Tumors
pediatric, MM-398, cyclophosphamide, irinotecan
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Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD
Call 214-648-5005
studyfinder@utsouthwestern.edu
Peter Van Buren
76950
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02680574
STU 052016-080
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Inclusion Criteria:

• ≥18 years of age
• Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m^2 at Screening and not expected to start dialysis within 6 months of Screening
• Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or during Screening
• Mean Screening HGB between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
Exclusion Criteria:

• Uncontrolled hypertension
• Severe heart failure at Screening (New York Heart Association Class IV)
• Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), urgent coronary revascularization, hospitalization for CHF, or stroke within 12 weeks prior to Screening
Drug: vadadustat, Drug: darbepoetin alfa
Anemia, Non-dialysis-dependent Chronic Kidney Disease
vadadustat, AKB-6548, Chronic kidney disease, anemia, CKD, chronic renal insufficiency, renal impairment, erythropoietin, kidney, renal, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, efficacy, safety, Phase 3, cardiovascular, NDD-CKD
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Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET

This study will formally address the hypothesis that FES-PET/CT measurement of ER expression predicts clinical benefit of first-line endocrine therapy in newly diagnosed ER+ metastatic breast cancer patients and establishes the repeatability of FES PET/CT.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Rathan Subramaniam
160833
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03065712
STU 032016-021
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Inclusion Criteria:

• Patients must be over 18 years old and capable and willing to provide informed consent.
• Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to PET/CT imaging per institution's standard of care;
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria;
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Medically stable as judged by patient's physician.
• Life expectancy must be estimated at > 6 months.
• Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FES are NOT eligible.
• Patients with liver failure are NOT eligible.
• Patient must NOT be breast-feeding.
• Histologically confirmed ER+ breast cancer either from a metastatic biopsy or from a primary breast tumor with imaging evidence of metastatic disease. The pathology report and either (1) tumor tissue (blocks or unstained slides) or (2) a photomicrograph of the ER IHC slide from at least one site of metastatic disease
• No prior endocrine therapy for metastatic disease is allowed (i.e. must be first-line endocrine therapy for metastatic disease). However, a history of adjuvant endocrine therapy is allowed, as long as the date of diagnosis of metastatic disease is > 2 years following initiation of adjuvant endocrine therapy. Patients who develop metastatic disease while still receiving adjuvant endocrine therapy must have a change in the type of endocrine agent used for subsequent metastatic disease treatment. Patients on blocking adjuvant therapy (with a blocking agent such as toremifene or tamoxifen) must be off the agents for a minimum of 60 days to allow for adequate uptake of FES
• Patients with human epidermal growth factor-2 positive (HER2+) metastatic tumors are NOT eligible
• Postmenopausal women, men, or premenopausal women for whom endocrine therapy (tamoxifen, aromatase inhibitor (AI) with or without ovarian suppression or fulvestrant), with or without a CDK4/6 inhibitor is planned after FES-PET/CT is completed
• Disease may be measurable (by RECIST 1.1 criteria) or non-measurable but must be present in at least one non-liver site, 1.5 cm or greater and visualized on PET/CT with [18F]-fluorodeoxyglucose (FDG). Patients with effusion only disease or disease only in the liver are not eligible for the study
• Patient must be able to lie still for a 20 to 30 minute PET/CT scan.
Exclusion Criteria:
. Patients not meeting the inclusion criteria.
Drug: F-18 Fluoroestradiol, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Laboratory Biomarker Analysis
Breast Cancer
Breast Cancer, PET/CT, FES, 18F Fluoroestradiol, Breast
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A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes

This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination with azacitidine in patients with IPSS-R high and very high risk MDS who are previously untreated with HMAs. Enrollment in this study will be limited to high/very high risk MDS because this group represents the highest unmet need, with median survival of less than 18 months. Stage 1 will be conducted as an open-label single arm in up to 40 subjects to assess if this regimen with a lower pracinostat dose results in a discontinuation rate that meets a predefined threshold and in efficacy that justifies expansion of enrollment into Stage 2. A discontinuation rate of approximately ≤10% in Stage 1, a rate comparable to that observed with azacitidine alone in study MEI-003, is considered desirable and supports expansion into Stage 2. Stage 2 will be conducted as a randomized, double-blind, placebo-controlled, two-arm design to confirm that the discontinuation rate observed in an open-label design can be reproduced in a placebo controlled design, and to provide unbiased information on efficacy and safety. Subjects will be randomized in a 1:1 ratio to one of the 2 treatment arms (Arm A, pracinostat + azacitidine and Arm B, placebo + azacitidine). Study drugs should be continued until disease progression or intolerable toxicity. It is important to note that the median time to achieving a response with azacitidine alone is 4 to 5 months. Furthermore, the median time to achieving a CR in study MEI-003 was 4 cycles. Therefore, early (<6 months) discontinuation of trial therapy for 'no response' should be avoided. The Medical Monitor should be contacted prior to discontinuing a subject from the study to discuss the rationale for discontinuation.
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Prapti Patel
103509
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03151304
STU 072017-095
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Inclusion Criteria:
1. Female or male subjects ≥18 years-of-age. 2. Histologically or cytologically documented diagnosis of MDS according to the World Health Organization (WHO) classification (Vardiman 2009, Arber 2016) with >5% and <20% bone marrow blasts by morphology and a peripheral white blood cell (WBC) count of <20,000/μL
• If WBC ≥20,000/μL, cytoreduction with hydroxyurea is permitted prior to enrollment. 3. Classified as high or very high risk according to the Revised International Prognostic Scoring System (IPSS-R) risk category. 4. Bone marrow biopsy (BMBx) within 28 days prior to first study treatment. 5. Clinical indication for treatment with azacitidine. 6. Previously untreated with HMAs (prior therapy with transfusions, hematopoietic growth factors, or immunosuppressive therapy is allowed). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 8. Adequate organ function as evidenced by:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × the upper limit of normal (ULN).
• Total bilirubin ≤1.5 × ULN or total bilirubin of ≤2 mg/dL, whichever is higher.
• Serum creatinine <2 mg/dL, or creatinine clearance ≤1.5 × ULN.
• QTcF interval ≤450 msec using the mean of triplicate electrocardiograms (ECGs). 9. Female subjects of childbearing potential and male subjects with female partners of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Female subjects of childbearing potential must not be breastfeeding, or planning to breastfeed, and must have a negative pregnancy test ≤7 days before first study drug administration. Male subjects must also refrain from donating sperm during their participation in the study. 10. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care. 11. Have the willingness and ability to understand the nature of this study and to comply with the study and follow-up procedures.
Exclusion Criteria:
1. Bone marrow blasts ≥20%, indicating a diagnosis of acute myeloid leukemia (AML). 2. Received any of the following within the specified time frame prior to administration of study medication:
• Any investigational agent within 14 days or 5 half-lives prior to enrollment, whichever is longer.
• Hydroxyurea within 48 hours prior to first day of study treatment.
• Hematopoietic growth factors: erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists at least 7 days (14 days for Aranesp), prior to study enrollment.
• Major surgery within 28 days prior to first study treatment. 3. Subjects that have not recovered from side effects of previous therapy. 4. Cardiopulmonary function criteria:
• Current unstable arrhythmia requiring treatment.
• History of symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV).
• History of myocardial infarction within 6 months of enrollment.
• Current unstable angina. 5. Prior treatment for MDS with the histone deacetylase (HDAC) inhibitors Zolinza (vorinostat), Belenodaq (belinostat), Farydak (panobinostat), Istodax (romidepsin/depsipetide), or investigational agent with significant action as an HDAC inhibitor. 6. Clinical evidence of central nervous system involvement. 7. Subjects with gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis). 8. Uncontrolled infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C. 9. Life-threatening illness unrelated to cancer or any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with participation in this study. 10. Presence of a malignant disease within the last 12 months, with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, non-melanomatous skin cancer, or malignancies treated with curative intent and no evidence of active disease in prior 12 months and felt to be low risk for recurrence. 11. An unwillingness or inability (including psychological, familial, sociological, or geographical conditions) to comply with trial and/or follow-up procedures as outlined in the protocol
Drug: Pracinostat, Drug: Azacitidine, Drug: Placebos
Myelodysplastic Syndromes
MDS
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Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) (TAHOE)

The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.
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Saad Khan
136971
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03061812
STU 032017-056
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Inclusion Criteria:

• Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen
• Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
• Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per the Central Radiographic Assessment Committee (CRAC).
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.
Exclusion Criteria:

• Participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class (NYHA) III
•IV within 6 months prior to their first dose of study drug.
• Participant has known leptomeningeal metastases.
• Participant has received more than one prior systemic therapy regimen for SCLC.
• Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
• Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
• Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
Drug: Rovalpituzumab tesirine, Drug: Topotecan
Small Cell Lung Cancer
Small cell lung cancer (SCLC), Delta-like protein 3 (DLL3), rovalpituzumab tesirine, topotecan, metastatic
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A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
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Paul Sue
157043
All
1 Year to 17 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT03241550
STU 072017-061
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Inclusion Criteria:

• Subject has sufficient venous access to permit administration of study drug (for the IV cohorts), collection of pharmacokinetic samples and monitoring of safety laboratories.
• Female subject must either:
• Be of non-childbearing potential: Clearly premenarchal or documented surgically sterile
• Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; and have a negative urine or serum pregnancy test at screening; and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study and for 28 days after the final study drug administration.
• Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 28 days after the final study drug administration.
• Female subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.
• Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
• Male subject who is of childbearing potential must not donate sperm starting at screening and throughout the study and, for 90 days after the final study drug administration.
• Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment.
• For oral cohorts: subject is able to swallow the oral capsule medication.
Exclusion Criteria:

• Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
• Subject has evidence of hepatic dysfunction defined as:
• Total bilirubin ≥ 3 times the upper limit of normal (ULN)
• Alanine transaminase or aspartate transaminase ≥ 5 times the ULN
• Known cirrhosis or chronic hepatic failure
• Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St. John's wort in the 5 days prior to the first administration of study drug.
• Subject has known history of allergy, hypersensitivity, or any serious reaction to any of the azole class antifungals.
• Subject has any condition which makes the subject unsuitable for study participation.
• Subject is unlikely to survive 30 days.
• Subject has received investigational therapy, with the exception of oncology drug trials, within 28 days or 5 half-lives, whichever is longer, prior to screening.
• For oral cohorts: The subject has gastrointestinal disease or has had a procedure that is expected to interfere with the oral absorption or tolerance of the study drug (e.g., functionally relevant gastrointestinal obstruction, mucositis/stomatitis, or frequent vomiting).
• Subject previously dosed with isavuconazonium sulfate.
Drug: isavuconazonium sulfate - intravenous, Drug: isavuconazonium sulfate - oral
Hematological Malignancy
invasive fungal disease, Cresemba®, Hematological malignancy, isavuconazonium sulfate, ASP9766, isavuconazole, pediatric population
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Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa) (bb2121)

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
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canceranswerline@utsouthwestern.edu
Larry Anderson
102991
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03361748
STU 092017-022
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Inclusion Criteria:
Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Documented diagnosis of multiple myeloma
• Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
• Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
• Must have received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
• Must be refractory to the last treatment regimen. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Subjects must have measurable disease, including at least one of the criteria below:
• Serum M-protein greater or equal to 1.0 g/dL
• Urine M-protein greater or equal to 200 mg/24 h
• Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment: 1. Subjects with known central nervous system involvement with myeloma. 2. History or presence of clinically relevant central nervous system (CNS) pathology. 3. Subjects with plasma cell leukemia. 4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5. Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy 8. Evidence of human immunodeficiency virus (HIV) infection. 9. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) 10. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV) 11. Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months. 12. Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission 13. Pregnant or lactating women. 14. Subject with known hypersensitivity to any component of bb2121 product
Biological: bb2121
Multiple Myeloma
Multiple Myeloma, Efficacy and Safety, BB2121, CAR T Cell, BCMA, Relapsed and Refractory
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Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.
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Hans Hammers
169573
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03117309
STU 062017-018
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Inclusion Criteria-Part A: Subject must meet all of the following applicable inclusion criteria to participate in this study:
• Patients must have histologically confirmed advanced RCC (any histology). Collecting duct tumors and tumors originating from the renal pelvis or upper urinary tract are considered of urothelial origin and are excluded from this protocol.
• Patients must have at least one measurable site of disease, per RECIST 1.1, that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
• ECOG performance status 0-2
• Have signed the current approved informed consent form Patients must have adequate organ function within 14 days prior to study entry as evidenced by screening laboratory values that must meet the following criteria: Hematological:
• White blood cell (WBC) ≥ 2000/µL
• Absolute Neutrophil Count (ANC) ≥ 1500/μL
• Platelets (Plt) ≥ 100 x103/μL
• Hemoglobin (Hgb) > 9.0 g/dL (with or without transfusion) Renal:
• Serum Creatinine ≤ 1.5 x ULN
• Calculated creatinine clearance1 ≥ 40 mL/min using Cockcroft-Gault formula Hepatic:
• Bilirubin2 ≤ 1.5× upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 3 × ULN
• Alanine aminotransferase (ALT) ≤ 3 × ULN
• Archival tissue is mandatory (a tumor biopsy- core or excisional) of a metastatic lesion obtained within 1 year prior to study registration (within 4 weeks preferred). Tumor tissue from nephrectomy and site of metastasis will be required. If archival tissue of a metastatic lesion obtained within the preceding year is not available, patients must have at least one site of disease (not including bone metastases) accessible for core needle or excisional biopsy. If archival tissue of a metastatic lesion is not available and biopsy of a new lesion is not feasible, the subject is not eligible for the study.
• Patients should not have received prior systemic therapy for metastatic RCC. Prior radiotherapy must have been completed at least 2 weeks prior to the administration of study drug. Patients must be 2 weeks from prior major surgery and 1 week from pre-treatment biopsy. Prior systemic adjuvant therapy (excluding with PD1 or CTLA4 pathway blockers) is allowed if treatment completed > 12 months previously.
• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of study drug.
• Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab.
• Women must not be breastfeeding
• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
• Be willing and able to comply with this protocol.
Exclusion Criteria:

• Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 2 weeks of more after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
• Patients with controlled brain metastases are allowed on protocol if they had solitary brain metastases that was surgically resected without recurrence or treated with SRS without progression x 4 weeks.
• Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
• Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen
• Active infection requiring systemic therapy
• Has any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial
• Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
• Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Allergies and Adverse Drug Reaction
• History of allergy to study drug components
• History of severe hypersensitivity reaction to any monoclonal antibody
• Known additional malignancies within the past 3 years (excluding basal of squamous cell skin cancers, CIS or localized prostate cancer that has been treated or is being observed) Inclusion/Exclusion Criteria- Part B
• Must meet eligibility criteria for initiation of Part A with the exception of being allowed to have prior nivolumab in Part A of this protocol
• Must have evidence of either RECIST 1.1 defined Disease Progression or Stable Disease 1 year after initiating nivolumab therapy
• Must undergo repeat tumor biopsy for acquisition of resistant tumor tissue
• Must not have had a Grade ≥ 3 irAE on nivolumab monotherapy
• Must not have untreated brain metastases
• Must not have had major surgery or radiation therapy within 14 days of starting study treatment
• Must not have active autoimmune disease
• Must not have a concurrent medical condition requiring use of systemic corticosteroids with prednisone >10 mg per day
• Must not have had prior systemic therapy for Stage IV RCC (except for nivolumab as part of part A of this protocol)
Drug: Nivolumab 240 mg, Drug: Ipilimumab 1mg/kg, Drug: Nivolumab 3mg/kg, Drug: Nivolumab 360mg
Advanced Renal Cell Carcinoma
Nivolumab, Ipilimumab, OPDIVO, IgG1 kappa immunoglobulin
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Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer

The purpose of this trial is to evaluate the effect of investigational drug nivolumab in combination with either gemcitabine/cisplatin chemotherapy, or in combination with another investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer. Gemcitabine/cisplatin is the standard of care treatment for biliary tract cancer. Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo) is FDA approved for the treatment of several cancers including metastatic melanoma, advanced lung, kidney, head & neck and bladder cancer. The combination of nivolumab and ipilimumab (Yervoy) is FDA approved for metastatic melanoma.
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Muhammad Beg
125541
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03101566
STU 082017-039
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Inclusion Criteria:

• Patients must have a pathologically confirmed adenocarcinoma of the biliary tract (intra-hepatic, extra-hepatic (hilar, distal) or gall bladder) that is not eligible for curative resection, transplantation, or ablative therapies.
• Patients may have received prior radiation, chemoembolization, radioembolization or other local ablative therapies or hepatic resection if completed ≥ 4 weeks prior to registration AND if patient has recovered to <= grade 1 toxicity.
• Patients must have radiographically measurable disease in at least one site not previously treated with radiation or liver directed therapy (including bland, chemo- or radio-embolization, or ablation) either within the liver or in a metastatic site.
• Age≥18 years
• Child-Pugh score of A (prognosis in chronic liver disease and cirrhosis)
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
• Ability to understand and willingness to sign IRB-approved informed consent
• Willing to provide archived tissue, if available, from a previous diagnostic biopsy
• Must be able to tolerate CT (computerized tomography) and/or MRI (magnetic resonance imaging) with contrast
• Adequate organ function obtained ≤ 2 weeks prior to registration
Exclusion Criteria:

• Patients may not have received prior systemic treatment (chemotherapy or targeted therapy) for advanced BTC (biliary tract cancer). Prior adjuvant chemotherapy is permitted provided it was completed > 6 months from registration.
• Must not have a diagnosis of immunodeficiency, or receiving systemic steroid therapy, or any other form of immunosuppressive therapy within 7 days prior to trial treatment.
• No known Hepatitis B, Hepatitis C, or HIV seropositivity. Testing is not required in absence of clinical suspicion.
• No prior history of organ transplantation or brain metastasis.
• Must not have undergone a major surgical procedure < 4 weeks prior to registration.
• Must not have an active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ. Patients with history of malignancy are eligible provided primary treatment of that cancer was completed > 1 year prior to registration and the patient is free of clinical or radiologic evidence of recurrent or progressive malignancy.
• Must have no ongoing active, uncontrolled infections
• Must not have received a live vaccine within 30 days of planned start of the study therapy.
• Must not have a psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.
• Women must not be pregnant or breastfeeding since nab-paclitaxel and/or gemcitabine may harm the fetus or child.
• Women of child-bearing potential and men must agree to use 2 methods of adequate contraception (hormonal plus barrier or 2 barrier forms) OR abstinence prior to study entry, for the duration of study participation and for 5 months (for women) and 7 months (for men) following completion of study therapy.
• Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Drug: Gemcitabine, Drug: Cisplatin, Drug: Ipilimumab, Drug: Nivolumab
Biliary Tract Neoplasms
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Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.
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Aditya Bagrodia
95190
Male
16 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02537548
STU 062017-008
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Inclusion Criteria:

• Pure seminoma after orchiectomy presenting with isolated retropreritoneal lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse. Relapse should be within 3 years
• Lymphadenopathy in the retroperitoneum: at least one lymph node 1-3 cm in greatest dimension, no lymph node > 3 cm in greatest dimension, no more than 2 lymph nodes 1-3 cm in greatest dimension
• Axial imaging of lymphadenopathy within 6 weeks of the date of RPLND
• Retroperitoneal lymphadenopathy must be within the RPLND template
• If there is borderline lymphadenopathy, defined as the largest retroperitoneal lymph node measuring 0.90
•0.99 cm in the greatest dimension, an abdominal computed tomography (CT) scan should be repeated (recommend interval of 6
•8 weeks); the same lymph node must demonstrate growth to >= 1.0 cm in the greatest dimension
• Biopsy is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with pure seminoma
• Chest imaging (x-ray, CT or magnetic resonance imaging [MRI]) negative for metastasis no more than 6 weeks prior to the date of RPLND
• Primary tumor excised by radical inguinal orchiectomy and pathology consistent with pure seminoma
• Serum alpha fetoprotein (AFP) not more than 1.5 times upper limit of normal, beta-human chorionic gonadotropin (HCG), lactate dehydrogenase (LDH) (per the local laboratory assay) within 14 days of RPLND
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Ability to understand and the willingness to sign a written informed consent
• Serum coagulation studies (INR/PTT) and platelet counts suitable for surgery per surgeon discretion.
Exclusion Criteria:

• Second primary malignancy
• History of receiving chemotherapy or radiotherapy
• Patients receiving any other investigational agent (s)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Other: Laboratory Biomarker Analysis, Procedure: Retroperitoneal Lymph Node Dissection
Lymphadenopathy, Stage I Testicular Seminoma, Stage II Testicular Seminoma
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Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.
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Tanya Watt
128737
All
up to 17 Months old
Phase 3
This study is NOT accepting healthy volunteers
NCT02176967
STU 072014-062
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Inclusion Criteria:

• Patients must be:
• < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or
• < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma
• Enrollment on ANBL00B1 is required for all newly diagnosed patients
• Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology
• Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index
• "Favorable" genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above
• "Unfavorable" genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)
• Only patients with MYCN non-amplified tumors are eligible for this study
• Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
• Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin
• Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma
• No prior tumor resection or biopsy
• Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes
• Group A1:
• > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in greatest diameter OR
• Patients less than 6 months of age with an adrenal primary tumor > 3.1 and < 5 cm in greatest diameter OR
• < 12 months of age with a non-adrenal primary site < 5 cm in greatest diameter
• Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in greatest diameter.
• Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
• No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.])
• No prior tumor resection, tumor biopsy ONLY
• Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1
• Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma
• No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with MYCN amplified tumors are not eligible
• Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure
• Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study
Other: Clinical Observation, Drug: Carboplatin, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study
Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma
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S0820, Adenoma and Second Primary Prevention Trial (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
Call 1-888-980-6050
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Farshid Araghizadeh
31724
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT01349881
STU 072016-004
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Inclusion Criteria:

• History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
• Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
• Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
• Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
• At least 30 days from completion of adjuvant chemo and RT.
• Presence of gastroesophageal reflux disease acceptable if controlled with medications
• Not receiving or planning to receive concomitant corticosteroids,nonsteroidal anti-inflammatory drugs(NSAIDs), nor anticoagulants. Maximum aspirin dose
• 100 mg per day or ≤ two 325 mg tablets per week.
• Able to swallow oral medications
• Laboratory: WBC ≥ 4.0 x 103/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
• Zubrod PS 0-1, 18 years of age or older
• Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
• Offered opportunity to participate in blood specimen banking
Exclusion Criteria:

• History of colon resection > 40 cm
• Mid-low rectal cancer
• Recurrent or metastatic disease
• High cardiovascular risk; Uncontrolled hypertension
• Planned radiation therapy or additional chemotherapy
• Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
• Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
• ≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
• Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
• Significant medical or psychiatric condition that would preclude study completion (8 years)
• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
• Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception
Drug: Eflornithine placebo & sulindac placebo, Drug: eflornithine & sulindac placebo, Drug: Eflornithine placebo & sulindac, Drug: Eflornithine plus sulindac
Colorectal Neoplasms
Eflornithine/sulindac prevention trial
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Hydrocortisone for BPD

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Roy Heyne
13172
All
up to 30 Weeks old
Phase 3
This study is NOT accepting healthy volunteers
NCT01353313
STU 082017-069
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Inclusion Criteria:

• infants <30 weeks estimated gestational age
• inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
• have received at least 7days of mechanical ventilation;
• are receiving mechanical ventilation through an endotracheal tube .
Exclusion Criteria:

• Major congenital anomalies
• Decision to limit support
• Indomethacin or ibuprofen treatment within 48 hours of study drug
• Previous corticosteroid treatment for BPD
• Received hydrocortisone for 14 or more cumulative days
• Received hydrocortisone within 7 days of study entry
Drug: Hydrocortisone, Drug: Placebo
Infant, Newborn, Bronchopulmonary Dysplasia, Infant, Small for Gestational Age, Infant, Premature, Infant, Very Low Birth Weight
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Intubation, Neurodevelopmental impairment
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A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02554812
STU 022016-032
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Inclusion Criteria:

• Histological or cytological diagnosis of advanced/metastatic solid tumor. Measurable disease by RECIST 1.1 with at least 1 measurable lesion that has not been previously irradiated. Availability of tumor specimen taken within 1 year prior to study entry, with no intervening systemic anti-cancer therapy. No prior PD-1/PDL-1 therapy allowed. Combination A: Phase 1b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, SCCHN, TNBC in any line of therapy, SCLC, 1st line NSCLC. 1st line NSCLC must demonstrate to express PD-L1. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination B: Phase 1b, patients with advanced solid tumors (NSCLC, SCCHN, melanoma) that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, or SCCHN. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination C: Ovarian cancer, SCCHN, NSCLC, gastric cancer, platinum resistant ovarian cancer. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. TGCT/PVNS that is either inoperable or requires extensive resection. Prior treatment with agents targeting CSF-1/CSF-1R not allowed. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination D: NSCLC, melanoma, SCCHN, bladder cancer. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed.
• ECOG performance status 0 or 1
• Estimated life expectancy of at least 3 months
• Adequate bone marrow, renal, and liver function
• Resolved acute effects of prior therapy
• Negative serum pregnancy test at screening
• Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after last dose
• Signed and dated informed consent
Exclusion Criteria:

• Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 14 days prior to study entry.
• Current or prior use of immunosuppressive medication within 7 days prior to study entry
• Active autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entry
• Known prior or suspected hypersensitivity to investigational products
• Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry
• Patients with known symptomatic brain metastases requiring steroids
• Previous high-dose chemotherapy requiring stem cell rescue
• Prior allogeneic stem cell transplant or organ graft
• Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
• Symptomatic pulmonary embolism within 6 months prior to study entry
• Known HIV or AIDS-related illness
• Active infection requiring systemic therapy
• Positive HBV or HCV test indicating acute or chronic infection
• Administration of a live vaccine within 4 weeks prior to study entry
• Diagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ≤6) prostate cancer
• Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation
• Persisting toxicity related to prior therapy >Grade 1
• Other severe acute or chronic medical condition
• Combo C :Existing periorbital edema.
• Combo C : Hypocalcemia, clinically significant bone disease or recent bone fracture (within 12 weeks prior study entry)
Drug: Avelumab, Drug: Utomilumab, Drug: PF-04518600, Drug: PD 0360324
Advanced Cancer
anti PD-L1, anti 4-1BB, OX40 agonist, anti M-CSF, Non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of head and neck (SCCHN), triple negative breast cancer (TNBC), gastric cancer, Small cell lung cancer (SCLC), bladder cancer, platinum resistant ovarian cancer, TGCT/PVNS
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Neoadjuvant Itraconazole in Non-small Cell Lung Cancer

The purpose of this study is to determine the pharmacodynamics effects of itraconazole in early-stage non-small cell lung cancer.
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David Gerber
53487
All
18 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT02357836
STU 122014-038
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Inclusion Criteria:
1. Histologically or cytologically proven NSCLC planned for surgical resection. All NSCLC histologic subtypes are eligible. Alternatively, patients in whom a diagnosis of NSCLC is highly suspected based on history and imaging studies and who are, therefore, scheduled for diagnostic biopsy and/or surgical resection will also be eligible for screening, enrollment, and study treatment if they meet all additional eligibility criteria. In the event that biopsies do not confirm NSCLC, such patients will be removed from study but monitored for any adverse events resulting from study participation. 2. No prior therapy but planned for surgical resection 3. Age ≥ 18 years. 4. ECOG 0-2 performance status 5. Adequate organ function as defined below:
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
• creatinine ≤ 2 X institutional upper limit of normal 6. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 6.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 7. Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
1. Subjects may not be receiving any investigational agents that would confound interpretation of study pharmacodynamic endpoints. 2. History of allergic reactions attributed to itraconazole or to compounds of similar chemical or biologic composition to itraconazole. 3. Uncontrolled, concurrent medical illness. 4. Active hepatitis or symptomatic liver disease. 5. History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure) or NYHA Class III or IV heart failure. 6. Current use of medications significantly affecting metabolism of itraconazole (certain anti-convulsants, corticosteroids). See 3.5 Drug Interactions in protocol. 7. Current evidence of hyperthyroidism (which would increase metabolism of itraconazole). 8. Pregnant or lactating female or any female trying to get pregnant. 9. Claustrophobia that would interfere with MRI studies anticipated to last 45-50 minutes. 10. Metal implants deemed at risk for migration during MRI studies. 11. CrCl < 45 mL/min (increased risk of nephrogenic systemic fibrosis [NSF] from MRI Gadolinium contrast). 12. Known allergy to MRI contrast.
Drug: Itraconazole
Non-Small Cell Lung Cancer
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Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)

In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
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Raquibul Hannan
125338
All
18 Years to 99 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT01818986
STU 102012-026
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Inclusion Criteria:
1. Biopsy proven prostate cancer 2. Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone (< 50ng/dl). Medical castration should continue until disease progression 3. Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist. 4. PSA ≥ 5 ng/ml 5. Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days 6. Adequate hematologic, renal, and liver function 7. Previous treatment with surgery, radiation or hormonal therapy is allowed. 8. Performance status ECOG 0 or 1. 9. Life expectancy of at least 6 months 10. Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell lymphotropic virus (HTLV)-1, Hepatitis B and C. 11. Age ≥ 18 years. 12. Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
1. Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months. 2. Subjects may not be receiving any other investigational agents for the treatment of prostate cancer. 3. Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 4. Subjects with malignant pleural effusions and malignant ascites 5. Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable. 6. Systemic immunosuppressive therapy in the past 28 days. 7. Use of any of the following within the past 28 days: Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate, Ketoconazole, high dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week). 8. Inability to tolerate contrast dye for baseline CT imaging. 9. Initiation or discontinuation of biphosphonate use within past 28 days. 10. Subjects with pathologic long-bone fractures 11. Subjects with spinal cord compression 12. Paget's disease of bone. 13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Drug: Sipuleucel-T, Radiation: Stereotactic Ablative Body Radiation
Metastatic Castrate-resistant Prostate Cancer, mCRPC
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02465060
STU 082015-079
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Inclusion Criteria:

• Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately
• Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:
• Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR
• Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 years
• Patients must have measurable disease
• Patients must meet one of the following criteria:
• Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient
• NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR
• Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected
• NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR
• Formalin-fixed paraffin-embedded tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of formalin-fixed paraffin-embedded (FFPE) tissue are:
• Tissue must have been collected within 6 months prior to pre-registration to Step 0
• Patient may receive treatment after tissue collection; however, lack of response must be documented prior to Step 1; the following restrictions apply:
• Enrollment onto another investigational study is not permitted
• Intervening therapy that constitutes a new, molecularly targeted therapy is not permitted; please note, immunotherapy is not considered molecularly targeted
• Continuation of an agent/regimen for which disease progression has been observed prior to biopsy is permitted, including targeted therapy
• A new immunotherapy regimen is permitted; but, lack of response must also be documented prior to registration to Step 0
• Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements OR
• Results from one of the designated outside laboratories indicate a "rare variant" that is an actionable mutation of interest (aMOI) for specific designated rare variant subprotocols; the following requirements apply:
• The outside laboratory notified the site that patient may be a potential candidate for MATCH due to a detected "rare variant"
• Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following entry on the EAY131 Step 0 screening step
• Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met
• NOTE: Other potential aMOIs that would be eligibility criteria for NON RARE arms, as determined by the above laboratories, are not applicable for direct treatment assignment on MATCH
• NOTE: Tumor tissue for the confirmation of "rare variant" by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratory
• Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted
• NOTE: Warfarin may not be started while enrolled in the EAY131 study
• Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
• Patients must not currently be receiving any other investigational agents
• Patients must not have any uncontrolled intercurrent illness including, but not limited to:
• Symptomatic congestive heart failure (New York Heart Association [NYHA] classification of III/IV)
• Unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration to Step 0, 2, 4, 6
• Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2)
• Psychiatric illness/social situations that would limit compliance with study requirements
• Intra-cardiac defibrillators
• Known cardiac metastases
• Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
• NOTE: To receive an agent, patient must not have any uncontrolled intercurrent illness such as ongoing or active infection; patients with infections unlikely to be resolved within 2 weeks following screening should not be considered for the trial
• Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible
• Patients who are human immunodeficiency virus (HIV)-positive are eligible if:
• CD4+ cell count greater or equal to 250 cells/mm^3
• If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used
• No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
• Probable long-term survival with HIV if cancer were not present
• Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease
• NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist
• NOTE: Patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment
• NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment
• Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below); patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)
• NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):
• Temporary steroid use for computed tomography (CT) imaging in setting of contrast allergy
• Low dose steroid use for appetite
• Chronic inhaled steroid use
• Steroid injections for joint disease
• Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease
• Topical steroid
• Steroids required to manage toxicity related to study treatment, as described in the subprotocols
• Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy
• NOTE: Steroids must be completed alongside last dose of chemotherapy
• Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Leukocytes >= 3,000/mcL
• Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Absolute neutrophil count >= 1,500/mcL
• Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Platelets >= 100,000/mcL
• NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL
• Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted)
• Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN (up to 5 times ULN in presence of liver metastases)
• Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:
• Resting corrected QT interval (QTc) =< 480 msec
• NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs
• The following only need to be assessed if the mean QTc > 480 msec
• Check potassium and magnesium serum levels
• Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc
• For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required
• For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc
• Patient must not have hypokalemia (value < institutional lower limit of normal)
• No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
• NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs
Drug: Adavosertib, Drug: Afatinib, Drug: Binimetinib, Drug: Capivasertib, Drug: Crizotinib, Other: Cytology Specimen Collection Procedure, Drug: Dabrafenib, Drug: Dasatinib, Drug: Defactinib, Drug: FGFR Inhibitor AZD4547, Other: Laboratory Biomarker Analysis, Drug: Larotrectinib, Biological: Nivolumab, Drug: Osimertinib, Drug: Palbociclib, Biological: Pertuzumab, Drug: PI3K-beta Inhibitor GSK2636771, Drug: Sapanisertib, Drug: Sunitinib Malate, Drug: Taselisib, Drug: Trametinib, Biological: Trastuzumab, Biological: Trastuzumab Emtansine, Drug: Vismodegib
Recurrent Melanoma, Lymphoma, Melanoma, Recurrent Uterine Corpus Carcinoma, Glioma, Recurrent Ovarian Carcinoma, Recurrent Breast Carcinoma, Recurrent Pancreatic Carcinoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Recurrent Bladder Carcinoma, Recurrent Prostate Carcinoma, Breast Carcinoma, Recurrent Cervical Carcinoma, Thyroid Gland Carcinoma, Recurrent Colon Carcinoma, Recurrent Malignant Solid Neoplasm, Esophageal Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Cervical Carcinoma, Colon Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma, Kidney Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Lung Carcinoma, Malignant Uterine Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Plasma Cell Myeloma, Prostate Carcinoma, Rectal Carcinoma, Recurrent Colorectal Carcinoma, Recurrent Esophageal Carcinoma, Recurrent Gastric Carcinoma, Recurrent Glioma, Recurrent Head and Neck Carcinoma, Recurrent Liver Carcinoma, Recurrent Lung Carcinoma, Recurrent Lymphoma, Recurrent Rectal Carcinoma, Recurrent Skin Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Skin Carcinoma, Uterine Corpus Cancer
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3)

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Nisha Unni
148963
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT01674140
STU 052016-023
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DISEASE CHARACTERISTICS:
• Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
• ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining
• HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER2 is negative if a single test (or all tests) performed in a tumor specimen show: 1. IHC negative (0 or 1+) 2. ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER2 equivocal is not eligible.
• Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed
• Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
• Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
• Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other
• Patients must be high risk by belonging to one of the following risk groups:
• Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care). Patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative.
• Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and either an Oncotype DX® RS > 25 (screened via S1007 or otherwise) or tumor tissue with pathological Grade III following local practice. If Oncotype DX is done, then RS must be > 25. If the test is not done, but the patient has Grade III disease then the patient is eligible and Oncotype DX does not need to be performed.
• Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes.
• Completion of neoadjuvant chemotherapy and 1 or more positive nodes pathologically determined prior to or after chemotherapy
• Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
• Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines
• Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
• Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation
• Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
• For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 5 cm
• All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy) PATIENT CHARACTERISTICS:
• Absolute Neutrophil Count ≥ 1,500/mL
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mL
• Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)
• Alkaline phosphatase ≤ 1.5 times IULN
• Serum creatinine level ≤ IULN
• Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values
• Patients must have a performance status of 0-2 by Zubrod criteria
• Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
• Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy
• Patients with known hepatitis are not eligible
• Patients must not have any known uncontrolled, underlying pulmonary disease
• Patients must be able to take oral medications
• Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Patients must not be pregnant or nursing
• Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
• In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices
• If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
• Patients must not be receiving or planning to receive trastuzumab
• Concurrent bisphosphonate therapy is allowed
• Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
• Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
• Patients must not be planning to receive any other anticancer drug for the duration of the study
• Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed
• Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment
• Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers
Drug: anastrozole, Drug: everolimus, Drug: exemestane, Drug: goserelin acetate, Drug: letrozole, Drug: leuprolide acetate, Drug: tamoxifen citrate, Other: placebo
Breast Cancer
estrogen receptor-positive breast cancer, HER2-negative breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, progesterone receptor-positive breast cancer, male breast cancer
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