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20 Study Matches

Identification and Validation of Biomarkers for Infections in Burns

In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.
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studyfinder@utsouthwestern.edu
Herbert Phelan
59840
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02457663
STU 062015-078
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Inclusion Criteria:

• Ages 18-80 years old
• Greater than 20% Total Body Surface Area burn
• Patient arrival to the burn center within 7 days of burn injury
Exclusion Criteria:

• Known history of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), human immunodeficiency virus (HIV)
• History of cancer within 5 years
• Pregnancy
• Burn injury due to chemical burns or deep electrical injury
• Inability to obtain informed consent
• Decision not to treat due to burn injury severity or futility as deemed by the clinical team at the time of admission (Note: This is a clinical determination of futility beyond which survival is rare. These are typically patients whose sum of Total Body Surface Area % burn and age (Baux score) exceeds 140 or 120 with severe inhalation injury.)
• Presence of anoxic brain injury that is not expected to result in complete recovery
Procedure: Blood Draw
Burns Involving 20% or More of Body Surface
Burns
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A Study of NKTR-262 in Combination With NKTR-214 and With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies (REVEAL)

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
James Brugarolas
80679
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03435640
STU 042018-024
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Inclusion Criteria:

• Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), ovarian carcinoma, renal cell carcinoma (RCC), colorectal cancer, urothelial carcinoma, or sarcoma.
• Life expectancy > 12 weeks as determined by the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Measurable disease per RECIST 1.1.
• Patients enrolled in Cohorts 1-5, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease.
• Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status.
• Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies.
• Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).
Exclusion Criteria:

• Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s).
• Patients treated with prior interleukin-2 (IL-2).
• Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines.
• Patients who have received systemic interferon (IFN)α within the previous 6 months prior to enrollment to the study.
• Other active malignancy, except non-melanomic skin cancer
• Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
• Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
• Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
• History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
• Unstable angina or myocardial infarction.
• Congestive heart failure (NYHA Class III or IV).
• Uncontrolled clinically significant arrhythmias.
• Need for > 2 antihypertensive medications for management of hypertension (including diuretics).
• Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic retinopathy, retinal hemorrhage, macular degeneration).
Drug: NKTR-262, Drug: NKTR-214, Drug: nivolumab
Sarcoma, Melanoma, Colorectal Cancer, Ovarian Cancer, Renal Cell Carcinoma, Triple Negative Breast Cancer, Urothelial Carcinoma, Merkel Cell Carcinoma
NKTR-214, NKTR-262, Nivolumab, Opdivo, Metastatic, Locally advanced, Relapsed/Refractory, TLR7/8, CD122
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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:

• ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)
• 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 the criteria below and have received results from one of the designated outside laboratories indicating a "rare variant" that is an actionable Mutation of Interest (aMOI) for specific select subprotocols.
• The following requirements apply:
• The outside laboratory specifically notified the site that patient may be a potential candidate for MATCH due to a detected "rare variant"; the outside lab reports are NOT sufficient for this purpose
• NOTE: The content and format of these specific notifications for the Outside Assay process will vary depending on the designated outside lab in question, as they are each responsible for their own outreach efforts; it is strongly recommended that the designated outside laboratory be contacted to confirm the format and receipt of this notification prior to registering any patients to Step 0
• Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following notification of treatment assignment
• NOTE: The receipt of this notification (and the start of the associated deadline for Step 1 registration) may occur shortly after Step 0 registration, since these patients will not be submitting tissue for screening purposes; however, for certain "rare variant" arms, submission of archival tissue for central immunohistochemistry (IHC) testing may be required
• 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
• There is no particular window of time after notification of potential eligibility from an outside lab in which the patient must be registered to Step 0, but treatment slots will be assigned on a first come, first serve basis to those who do register to Step 0, and are not held for those notified of potential eligibility who do not register to Step 0
• Patients may have received other non-targeted, immunotherapy or targeted treatment between the prior genetic testing at the outside lab and registration to Step 0; the decision to stop such treatment in favor of participation in MATCH, if no further clinical benefit is expected, is per the treating physician's discretion; documentation of a lack of response to the prior treatment is not required in these cases
• NOTE: Other potential aMOIs that would be eligibility criteria for "NON RARE" arms, as determined by the designated laboratories, are not applicable for this process in 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: For patients entering the study via the original screening process, 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 only intervening treatment permitted is prior therapy that the patient already received prior to Step 0 registration; 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: e.g. 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
• 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 (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• 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
• 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
• As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• 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
• ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1)
• If patients have been biopsied or submitted archived tumor tissue obtained within the last 6 months for assessment with the MATCH assays, patients may receive non-protocol treatment after biopsy/tissue submission (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; for pat
Drug: Adavosertib, Drug: Afatinib, Drug: Binimetinib, Drug: Capivasertib, Drug: Copanlisib, Drug: Crizotinib, Other: Cytology Specimen Collection Procedure, Drug: Dabrafenib, Drug: Dasatinib, Drug: Defactinib, Drug: Erdafitinib, 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 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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Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers

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canceranswerline@utsouthwestern.edu
Theodore Laetsch
148176
All
1 Month and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03215511
STU 112017-078
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Key
Inclusion Criteria:

• Advanced solid tumor for which, in the opinion of the Investigator, no other standard therapy offers greater benefit.
• A solid tumor diagnosis in the setting of: 1. a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor 2. a documented NTRK fusion unresponsive to a prior TRK inhibitor 3. a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
• NTRK gene fusions will be identified via a CLIA certified (or equivalent) laboratory. Exception: Patients with Infantile Fibrosarcoma (IFS) and congenital mesoblastic nephroma (CMN) may be enrolled based on ETV6+ FISH test without identifying NTRK3
• Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3 (age ≥16) or Lansky Performance Score (LPS) ≥40% (age<16). If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Status (KPS) (age ≥16) or LPS (age<16) ≥ 50%
• Life expectancy > 4 weeks
• Adequate hematologic, hepatic and renal function.
• Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms and steroid use (if applicable) have been stable for 7 days prior to the first dose of LOXO-195
• Ability to receive study drug orally or by enteral administration Key
Exclusion Criteria:

• Required treatment with certain strong CYP3A4 inhibitors or inducers.
• Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of LOXO-195 or prolongation of the QT interval corrected (QTcF) > 480 msec within the past 6 months
• Major surgery within 7 days of enrollment
• Uncontrolled systemic bacterial, fungal or viral infection
• Pregnancy or lactation.
• Known hypersensitivity to any of the components of LOXO-195 or Ora-Sweet® SF and OraOlus, for patients receiving liquid suspension
Drug: LOXO-195
Sarcoma, Melanoma, Colorectal Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Congenital Mesoblastic Nephroma, Glioblastoma, Ovarian Neoplasms, Cholangiocarcinoma, Pancreatic Neoplasms, Head and Neck Squamous Cell Carcinoma, Central Nervous System Neoplasms, Thyroid Cancer, Thyroid Neoplasms, Skin Carcinoma, Biliary Tract Neoplasms, Astrocytoma, Salivary Gland Neoplasms, Brain Neoplasm, Primary, Bile Duct Neoplasms, Pontine Glioma, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms, Nerve Tissue, Nevi and Melanomas, Intestinal Neoplasms, GIST, Malignant Peripheral Nerve Sheath Tumors, Breast Secretory Carcinoma, Uterine Neoplasms, Fibrosarcoma, Infantile Fibrosarcoma
NTRK Fusion Positive, LOXO-195, Loxo, TRK, TRK Fusion, NTRK1, NTRK2, NTRK3, TRKA, TRKB, TRKC, NTRK, ETV6, fusion, tumors, CNS tumors, solid tumors, central nervous system tumors, advanced cancer, primary CNS tumor, Advanced CNS tumor, Metastatic CNS tumor, NTRK1 fusion, NTRK2 fusion, NTRK3 fusion, ETV6-NTRK3, ETV6 fusion, Metastatic cancer, Cancer of Unknown Primary Site, Pediatric, NTRK1 gene rearrangement, NTRK2 gene rearrangement, NTRK3 gene rearrangement, ETV6 gene rearrangement, NTRK gene rearragements, Congenital Nephroma, Metastatic Infantile Fibrosarcoma, Advanced Infantile Fibrosarcoma
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NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing (Cardinal PRO)

This study is designed to assess the efficacy and economics of two NPWT branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy.
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Lawrence Lavery
116716
All
18 Years to 89 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02519621
STU 032015-099
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Inclusion Criteria:

• Presents with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
• Wound presents with full thickness loss of epidermis and dermis
• The presentation of a wound that in the opinion of the investigators will require surgical debridement, and the wound is expected to be a good candidate for NPWT and eventual wound closure.
• ABI≥0.5 or toe pressures >30 PVR/mmHg
• Subject is willing and able to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described herein.
• 18 years of age or older
Exclusion Criteria:

• Does not present with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft, or a definitive diagnosis cannot be made, as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
• Wound does not present with full thickness loss of epidermis and dermis
• ABI<0.5 or toe pressures <30 PVR/mmHg
• Subject is not willing or is not able or it is not medically prudent for the subject to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described.
• Subject is unwilling or unable to use the NPWT device at home
• Active Charcot arthropathy
• Collagen vascular disease
• Scleroderma
• Non-enteric and unexplored fistula
• Necrotic tissue with eschar present after debridement
• General skin disorder in the area of the wound such as psoriasis or penicilitis
• Malnutrition (defined as BMI <19)
• Hypercoagulable state based on documentation in their medical record
• Acute deep vein thrombosis
• Current active malignancy in the wound
• Current melanoma or history of melanoma at the wound
• Current active or history of invasive squamous cell carcinoma at the wound
• Sepsis (defined as positive blood culture with leukocytosis) and temperature >101.5 at the time of screening
• Significant Hematologic disorders EXCLUDING anemia
• HIV
• Fever at screening > 101.5
• Deep X-ray therapy
• Untreated bone or soft tissue infection (osteomyelitis)
• Any concomitant illness(es) or medical condition(s) that in the opinion of the investigator would render the subject not suited for study participation
• Subject is taking a regimen of any medication(s) in a significant enough dosage that may affect chronic wound healing, including corticosteroid, chemotherapeutic and non-steroidal anti-inflammatory (NSAID) medications
• Less than 18 years of age
• Developmental disability/significant psychological disorder that could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
• Females currently pregnant or planning pregnancy during the course of intended participation in the study
• Active alcohol or substance abuse in the opinion of the investigator that could impair the subjects ability to provide informed consent, participate in the study protocol or record study measures.
Device: NPWT PRO without irrigation, Device: NPWT PRO with irrigation, Device: KCI Ulta
Partial-thickness Burn, Ulcer
diabetic ulcer, pressure ulcer, chronic or traumatic wound, sub-acute or dehisced wound
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Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

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studyfinder@utsouthwestern.edu
Arturo Dominguez
52206
All
18 Years to 75 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT03239470
STU 052017-057
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Inclusion Criteria:

• Ability to provide informed consent;
• Diagnosis of Pemphigus Vulgaris (PV) or Pemphigus Foliaceus (PF), defined by H&E staining (e.g., Haemotoxylin and Eosin) and direct immunofluorescence staining of skin biopsy at any time prior to enrollment;
• Pemphigus treated with systemic corticosteroids within the 2 years prior to screening (historic or current);
• Presence of:
• anti-Dsg3 antibodies (>20.0 U/ml) at screening visit consistent with diagnosis of pemphigus vulgaris or,
• anti-Dsg1 antibodies (>20.0U/ml) at screening visit consistent with diagnosis of pemphigus foliaceus.
• Active of PV or PF as defined by Pemphigus Disease Area Index (PDAI) overall activity score 3-10 at screening visit, and PDAI overall activity score 1-12 at baseline visit;
• Positive test for Epstein-Barr Virus (EBV) antibody; and
• Adequate venous access to support draw of 400 ml whole blood and infusion of investigational therapy.
Exclusion Criteria:

• Initiation of systemic corticosteroid therapy, prednisone dose > 25 mg/d (or equivalent) or change in prednisone dose within 4 weeks prior to screening;
• Addition of a new medication, or change in the dose of any background medication used to treat any aspect of pemphigus within the timeframes listed below. Specifically:
• methotrexate, mycophenolate mofetil, mycophenolic acid, azathioprine, cyclosporine or dapsone within the 6 weeks prior to screening or in the time between screening and study drug infusion,
• intravenous Immunoglobulin (IVIG) within 12 weeks prior to screening or in the time between screening and study drug infusion (subjects on IVIG must be on stable dose for at least 12 weeks prior to screening),
• treatment with cyclophosphamide within 12 weeks prior to screening or in the time between screening and study drug infusion.
• Doses of background medications at screening:
• methotrexate > 25 mg/week,
• mycophenolate mofetil > 3000 mg/d,
• mycophenolic acid > 1080 mg/bid,
• azathioprine > 200 mg/d,
• cyclosporine > 2 mg/kg/d,
• dapsone >250 mg/d,or
• intravenous immunoglobulin (IVIG) > 4mg/kg monthly.
• Use of rituximab within the 12 months prior to screening;
• Change in dosing frequency, concentration, or applied surface area of topical steroids and/or topical calcineurin inhibitors within 2 weeks prior to screening;
• Paraneoplastic pemphigus;
• Pemphigus erythematosus;
• Pemphigus vegetans;
• Immunoglobulin A (IgA) pemphigus;
• Drug-induced pemphigus;
• Blood donation within 10 weeks prior to baseline visit (Day 0);
• Hemoglobin < 10 g/dL;
• White blood cell (WBC) count < 3,000/ mm^3 (equivalent to < 3 x10^9/L);
• Lymphocyte count < 800/mm^3 (equivalent to < 0.8 x10^9/L);
• Absolute neutrophil count < 1,500/mm^3 (equivalent to < 1.5 x10^9/L);
• Platelets < 100,000/mm^3 (equivalent to < 100 x 10^9/L);
• Liver function test [aspartate aminotransferase (AST)], alanine aminotransferase (ALT), or alkaline phosphatase (ALK)] results that are ≥ 2 times the upper limit of normal (ULN);
• Direct bilirubin > ULN;
• End stage renal disease [estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation];
• At or within three months of screening:
• a positive QuantiFERON(R)-TB Gold test or positive purified protein derivative tuberculin skin test (PPD) [>5mm induration, regardless of Bacille Calmette Guerin (BCG) vaccine administration] unless completion of treatment has been documented for active Tuberculosis (TB),
• an indeterminate QuantiFERON (R)-TB Gold test unless followed by a subsequent negative PPD or negative QuantiFERON(R)-TB Gold test as well as a consultation with and clearance by local infectious disease (ID) department.
• Recent or ongoing active bacterial, viral, fungal, or opportunistic infections requiring systemic anti-infective therapy;
• Evidence of current or prior infection with human immunodeficiency virus (HIV), hepatitis B [as assessed by HBsAg and anti-hepatitis B core antigen (HBc) Ab] or hepatitis C [as assessed by anti-Hepatitis C Virus (anti-HCV) Ab];
• Detectable circulating EBV or Cytomegalovirus (CMV) genomes or active infection;
• Chronic infection that is currently being treated with suppressive anti-infective therapy, including but not limited to tuberculosis, pneumocystis, CMV, herpes zoster, and atypical mycobacteria, with the exception of historical orolabial or localized cutaneous herpes simplex infections treated with suppressive anti- viral therapy;
• Receipt of a live-attenuated vaccine within 12 months prior to screening;
• Concomitant malignancies or a history of malignancy, with the exception of completely treated basal cell carcinoma of the skin;
• Pregnancy;
• Lactating or breastfeeding;
• Unwilling or unable to use reliable method(s) of contraception:
• For females of child-bearing potential, from four weeks prior to Day 0 through 1 year after Treg dosing;
• For males, from the day of Treg infusion (baseline visit) to three months after Treg infusion.
• Use of an investigational therapeutic medication, or other biologic medications except rituximab, within the past 90 days, or 5 half-lives prior to screening, whichever is greater;
• Concomitant medical condition that places the subject at risk by participating in this study, including but not limited to:
• another severe, systemic autoimmune disease or condition (besides pemphigus) requiring systemic immunosuppressive therapy (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), systemic sclerosis, primary Sjogren's syndrome, primary vasculitis, psoriasis, multiple sclerosis, ankylosing spondylitis, and inflammatory bowel disease), or
• severe, progressive, or poorly controlled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or
• history of significant infection or recurrent infection that, in the investigator's opinion, places the subject at risk by participating in this study, or
• any other concomitant medical condition that, in the investigator's opinion, places the subject at risk by participating in this study.
• Comorbidities requiring glucocorticoid therapy, including those which have required three or more courses of systemic glucocorticoids within the previous 12 months;
• Current or history within the past year of substance abuse; or
• Inability to comply with study and follow-up procedures.
Biological: Cohort 1: 2.5 x 10^8 PolyTregs, Biological: Cohort 2: 10x10^8 PolyTregs
Pemphigus Foliaceus, Pemphigus Vulgaris
autologous polyclonal regulatory T cell therapy, PolyTregs, open-label, Phase 1 (safety)
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The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury (RE-ENERGIZE)

The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries. 3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care. The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 2,700 patients in 80 sites: 1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality? 2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?
Call 214-648-5005
studyfinder@utsouthwestern.edu
Herbert Phelan
59840
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT00985205
STU 012016-031
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Inclusion Criteria:
1. Deep 2nd and/or 3rd degree burns requiring grafting 2. Patient meets one of the following 4 criteria: 1. Patients 18
•39 years of age with ≥ 20% TBSA* burn 2. Patients 18
•39 years of age with ≥ 15% TBSA* burn and with inhalation injury 3. Patients 40
•59 years of age with ≥ 15% TBSA* burn 4. Patients ≥ 60 years of age ≥ 10% TBSA* *TBSA
•Total Body Surface Area
Exclusion Criteria:
1. > 72 hrs from admission to ICU to time of consent. 2. Patients younger than 18 years of age. 3. a) Patients without known renal disease and renal dysfunction defined as a serum creatinine >171 µmol/L or a urine output of less than 500 mL/last 24 hours (or 80 mL/last 4 hours if a 24 hour period of observation is not available). b) Patients with acute on chronic renal failure (pre-dialysis) with an absolute increase of >80 µmol/L from baseline or pre-admission creatinine or a urine output of <500 mL/last 24 hours (or 80 mL/last 4 hours). c) Patients with chronic renal failure on dialysis will be excluded. 4. Liver cirrhosis
•Child-Pugh class C liver disease 5. Pregnant or lactating females. 6. Contra-indication for EN: intestinal occlusion or perforation, intra-abdominal injury. 7. Patients with injuries from high voltage electrical contact. 8. Patients who are moribund (not expected to survive the next 72 hours). 9. Patients with extreme body sizes: BMI < 18 or > 50 10. Enrollment in another industry sponsored ICU intervention study. 11. Received glutamine supplement for > 24 hrs prior to randomization 12. Known allergy to maltodextrin, corn starch, corn, corn products or glutamine.
Dietary Supplement: Enteral Glutamine, Dietary Supplement: Placebo
Burns
Randomized Clinical Trial, Glutamine, Themal Burn Injuries, Nutrition, Outcome Assessment, Critical Care, Total Body Surface Area
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A Study of Ruxolitinib Phosphate Cream in Subjects With Vitiligo

The purpose of this study is to examine the efficacy, safety, and tolerability of INCB018424 cream in subjects with vitiligo.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Amit Pandya
15504
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03099304
STU 042017-027
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Inclusion Criteria:

• Clinical diagnosis of vitiligo.
• Vitiligo with depigmented areas including:
• at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm [without digits]) AND
• at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints [palm plus 5 digits]).
• Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion Criteria:

• Conditions at baseline that would interfere with evaluation of vitiligo.
• Participants who are receiving any kind of phototherapy, including tanning beds.
• Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
• Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
• Participants who have received any of the following treatments within the minimum specified timeframes.
• Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
• Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
• Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
• Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
• Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
• Participants with protocol-defined cytopenias at screening
• Participants with severely impaired liver function.
• Participants with impaired renal function.
• Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
• Participants who have previously received JAK inhibitor therapy, systemic or topical.
Drug: Ruxolitinib cream, Drug: Vehicle cream
Vitiligo
Vitiligo, depigmenting disorder, topical JAK inhibitor
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A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo

Call 214-648-5005
studyfinder@utsouthwestern.edu
Amit Pandya
15504
All
18 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03468855
STU 032018-047
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Inclusion Criteria:
1. Subject has a clinical diagnosis of new onset or actively progressing non-segmental facial vitiligo or worsening of existing facial lesions within the past 6 months. 2. Subject has non-segmental facial vitiligo effecting at least 0.25% total body surface area (TBSA) (excluding the upper and lower eyelids, mucosal lip areas and forehead and chin areas covered by the stereotactic positioning device for photography) with at least one area of the face with normal pigmentation. 3. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit and must agree to use an approved method of highly effective birth control for the duration of the study and for 30 days after last study medication application. 4. Subject is in good general health and free of any known disease state or physical condition which, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation. 5. Subject agrees to refrain from any other treatments for vitiligo from the screening visit through the final follow-up visit. Over the counter (OTC) preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion Criteria:
1. Subject with evidence of poliosis (white hairs) in > 50% of their facial vitiligo lesions. 2. Subject with total facial depigmentation. 3. Subject with spontaneous ongoing repigmentation (documented based on the subject's reporting in the last 3 months). 4. Subject who has segmental vitiligo. 5. Subject who has failed phototherapy. Failed phototherapy is defined as failure to achieve satisfactory repigmentation following adequately delivered phototherapy as determined by the investigator. 6. Subject currently has, or has a history of, skin disease (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments. 7. Subject has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (i.e.,renal disease), hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation. 8. Subject currently has a history of, current, or suspected systemic or cutaneous malignancy and/or lymphoproliferative disease, other than a history of adequately treated, well healed and completely cleared non-melanoma skin cancers (e.g., basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease. 9. Subject currently has evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or a history of incompletely treated or untreated tuberculosis. Subjects who have initiated therapy for latent tuberculosis for at least 2 weeks and agree to continue their therapy through completion may participate. 10. Subject has a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the baseline visit. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study. 11. Subject has herpes zoster or cytomegalovirus (CMV) that resolved within 8 weeks prior to Visit 1. 12. Subject has a history of frequent outbreaks of oral Herpes Simplex Virus defined as more than 4 episodes per year. 13. Subjects previously treated with depigmenting agents. 14. Clinically significant laboratory abnormalities at screening that in the opinion of the investigator, would make the subject a poor candidate for the study. 15. Subject who has an absolute neutrophil count <1,000/mm3, or platelet count < 50,000/mL. 16. Subject unable to comply with the required washout periods 17. Subject who has participated in any investigational drug or device trial, regardless of indication in which administration of an investigational drug or device occurred within 30 days or 5 half-lives (whichever is longer) of screening (Visit 1). Note that investigational treatment for vitiligo (in any body area) requires a longer washout 18. Subjects with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening. Subjects under treatment with stable thyroid replacement who have a free T4 and TSH within the normal range may participate. 19. Subject has history of sensitivity to any of the ingredients in the study medication. 20. Subject has a history of, or current alcohol or drug abuse within 2 years of study enrollment. 21. Screening ECG findings of: 1. QTcF >450msec for males or >470msec for females (use of the ECG algorithm is acceptable for this purpose) 2. Heart rate ≤ 45 or ≥ 100 beats/minutes 3. Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm (ectopic atrial rhythm) 4. Conduction disturbance including PR >240msec, pre-excitation (delta wave and PR <120msec), second degree or higher AV block 5. Acute or chronic signs of ischemia. 6. Left Bundle Branch Block 7. Prior myocardial infarction
Drug: ATI-50002 topical solution
Vitiligo
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Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers (EO2)

This is a pilot study. The investigators plan a cohort study of 10 patients with a diabetic foot ulcer (DFU). Study duration will be three weeks. Patients will be consented and undergo debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue samples will be taken at this visit during standard of care wound debridement and these tissue samples of the wound would normally be removed as part of routine debridement. These tissue samples of the wound will be used for gene expression and bacterial analysis(research). The patient will then receive topical oxygen therapy using the TransCu O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after routine wound debridement, and patient will receive instructions for home use of the device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study window of 5 days., Digital photos of the wound, acetate tracing of the wound and vascular evaluations(SensiLase, Transcutaneous oxygen measurements, Hyperspectral imaging) will be performed at each study visit(research).Tissue samples will be taken during standard of care wound debridement at every study visit. Results of the data analysis from this project will be used to inform the design of a larger randomized clinical trial.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Lawrence Lavery
116716
All
18 Years to 89 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02501538
STU 012015-051
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Inclusion Criteria:

• Male or female subjects of all races and ethnicities, age 18-89
• Diagnosis of diabetes mellitus
• Has a diabetic foot ulcer
Exclusion Criteria:

• End-stage renal disease (ESRD)
• Has untreated foot ulcer at time of study
• HIV, hepatitis, autoimmune disease, Systemic lupus erythematous (SLE), Raynaud's disease
• Ankle-Brachial Index (ABI) < 0.4
• Unable or unwilling to provide informed consent
Device: Transcutaneous O2 device
Foot Ulcer, Diabetic
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A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer: - advanced melanoma (6 months to <18 years of age), - advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age), - relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or - advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age). Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Theodore Laetsch
148176
All
6 Months to 17 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02332668
STU 052016-090
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Inclusion Criteria:

• Between 6 months and <18 years of age (or between 3 years and <18 years of age for rrcHL participants) on day of signing informed consent/assent (the first 3 participants dosed in Part 1 are to be ≥ 6 years of age)
• Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate
• Any number of prior treatment regimens
• Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
• Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
• Measurable disease based on RECIST 1.1 (Or based on IWG [Cheson, 2007] [i.e., measurement must be >15 mm in longest diameter or >10 mm in short axis] for rrcHL participants)
• Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
• Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants >16 years of age
• Adequate organ function
• Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
• Female participants of childbearing potential must be willing to use 2 methods of contraception 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
• Male participants of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication
Exclusion Criteria:

• Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation/randomization
• Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization
• Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
• Prior radiotherapy within 2 weeks of start of study treatment
• Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Tumor(s) involving the brain stem
• Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
• Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Active infection requiring systemic therapy
• Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication
• Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 [CTLA-4], OX-40, CD137)
• Human immunodeficiency virus (HIV)
• Hepatitis B or C
• Known history of active tuberculosis (TB; Bacillus tuberculosis)
• Received a live vaccine within 30 days of planned start of study medication
• Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant >5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease [GVHD].)
• History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study
• Known psychiatric or substance abuse disorders that would interfere with the requirements of the study
Biological: Pembrolizumab
Lymphoma, Melanoma, Classical Hodgkin Lymphoma, Solid Tumor, Microsatellite-instability-high Solid Tumor
PD1, PD-1, PDL1, PD-L1, cHL, MSI-H
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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Jade Homsi
175558
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02568267
STU 012016-042
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Inclusion Criteria:

• Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
•Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria
• For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
• Measurable or evaluable disease
• Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
• Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
•Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
• At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
• At least 4 weeks must have elapsed since completion of antibody-directed therapy
• Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
• Adequate organ function as defined per protocol
• Ability to swallow entrectinib intact
• Other protocol specified criteria
Exclusion Criteria:

• Current participation in another therapeutic clinical trial
• Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
•Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
• History of other previous cancer that would interfere with the determination of safety or efficacy
• Incomplete recovery from any surgery
• History of non-pharmacologically induced prolonged QTc interval
• History of additional risk factors for torsade de pointes
• Peripheral neuropathy Grade ≥ 2
• Known active infections
• Active gastrointestinal disease or other malabsorption syndromes
• Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
• Other protocol specified criteria
Drug: Entrectinib
Non-Small Cell Lung Cancer, Breast Cancer, Melanoma, Pancreatic Cancer, Colorectal Cancer, Papillary Thyroid Cancer, Ovarian Cancer, Renal Cell Carcinoma, Cholangiocarcinoma, Neuroendocrine Tumors, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Primary Brain Tumors, Sarcomas, Salivary Gland Cancers, Adult Solid Tumor
Entrectinib, RXDX-101, TrkA, TrkB, TrkC, NTRK1, NTRK2, NTRK3, ROS1, ALK, Trk Fusions, NTRK Gene Rearrangements, ROS1 Fusions, ROS1 Gene Rearrangements, ALK Fusions, ALK Gene Rearrangements, Basket study, Non-small cell lung cancer, Colorectal cancer, Salivary gland cancers, Primary brain tumors, Melanoma, Sarcomas, Papillary thyroid cancer, Renal cell cancer, Pancreatic cancer, Breast cancer, Cholangiocarcinoma, Head & Neck cancers, Ovarian cancer, Neuroendocrine tumors, Anaplastic Large Cell Lymphoma
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Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Theodore Laetsch
148176
All
12 Months to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03155620
STU 072017-080
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Inclusion Criteria:

• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis [LCH], juvenile xanthogranuloma [JXG], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); please note: Patients with Hodgkin lymphoma are not eligible
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have an formalin-fixed paraffin-embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
• Please note: Samples that have been decalcified using standardly utilized acid-based decalcification methods are not generally suitable for MATCH study testing; the nucleic acids will have been degraded in the decalcification process
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621SC screening protocol, but will need to meet all criteria prior to enrollment on any assigned treatment subprotocol. Patients must be enrolled onto a subprotocol within 12 weeks (84 days) of treatment assignment
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or CSF
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
• Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total-body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
• X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6
• Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
• Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1
• Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
• Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
• Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Serum glutamate pyruvate transaminase (SGPT) (alanine transferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Exclusion Criteria:

• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications
• Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
• Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
• Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ transplant are not eligible
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols
Procedure: Biopsy, Procedure: Biospecimen Collection, Drug: Ensartinib, Drug: Erdafitinib, Other: Laboratory Biomarker Analysis, Drug: Larotrectinib, Procedure: Mutation Carrier Screening, Drug: Olaparib, Drug: Palbociclib, Other: Pharmacological Study, Drug: PI3K/mTOR Inhibitor LY3023414, Drug: Selumetinib Sulfate, Drug: Tazemetostat, Drug: Ulixertinib, Drug: Vemurafenib
Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Neuroblastoma, Malignant Glioma, Recurrent Osteosarcoma, Recurrent Childhood Ependymoma, Recurrent Malignant Solid Neoplasm, Recurrent Childhood Medulloblastoma, Recurrent Childhood Non-Hodgkin Lymphoma, Advanced Malignant Solid Neoplasm, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Wilms Tumor, Recurrent Glioma, Refractory Malignant Solid Neoplasm, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Childhood Langerhans Cell Histiocytosis, Histiocytic Sarcoma, Juvenile Xanthogranuloma, Recurrent Central Nervous System Neoplasm, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Peripheral Primitive Neuroectodermal Tumor, Refractory Central Nervous System Neoplasm, Refractory Childhood Malignant Germ Cell Tumor, Refractory Langerhans Cell Histiocytosis, Refractory Neuroblastoma, Rhabdoid Tumor, Stage III Osteosarcoma AJCC v7, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7, Refractory Non-Hodgkin Lymphoma, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma, Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma, Recurrent Rhabdoid Tumor, Refractory Medulloblastoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Ewing Sarcoma, Refractory Glioma, Refractory Hepatoblastoma, Refractory Rhabdomyosarcoma
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Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy (PROSPER)

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Vitaly Margulis
49444
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03055013
STU 032017-074
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Inclusion Criteria:

• ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):
• Patients with a renal mass consistent with a clinical stage >= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned
• Patients must have no clinical or radiological evidence of distant metastases (M0) unless the presumed M1 disease can be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or within a 12 week window from the date of the initial procedure such that the patient is considered "no evidence of disease" (M1 NED)
• Permitted sites of oligo-metastases: lung, adrenal, nodes, pancreas, soft tissue or skin; liver or bone metastases are not permitted
• No more than 3 metastases are permitted and all must be able to be removed or definitively treated within 12 weeks of the primary tumor resection
• If histological confirmation of RCC has not been done within 12 months prior to pre-registration (Step 0), patient must be willing to undergo a core biopsy for this purpose if randomized to Arm H
• NOTE: This can be a (1) standard of care diagnostic biopsy or (2) a research biopsy following assignment to Arm H or a planned metastasectomy before or after randomization; if the biopsy performed following pre-registration (Step 0) clearly demonstrates a benign condition, oncocytoma or a different type of cancer that is not RCC, the patient is not eligible for registration (Step 1); a non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator
• NOTE: Patients randomized to Arm O (Observation) are permitted to register to Step 1 (Arm B) immediately following pre-registration assignment to Arm O, regardless of whether or not they have had a standard of care diagnostic biopsy
• No prior systemic or local anti-cancer therapy for the current RCC is permitted
• Partial nephrectomy for prior RCC
• Metastasectomy for the current RCC diagnosis is not allowed unless performed to render patient NED (in addition to the planned nephrectomy) within 6 months of the current diagnosis
• Radiation therapyto the bilateral kidney or any distant metastatic sites, is not allowed unless administered to render patient NED within 6 months of the current diagnosis
• Current or past antineoplastic systemic therapies for RCC are not allowed: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
• Prior treatment with an 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
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
• Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
• Patients with a prior RCC that was treated > 5 years before, are eligible if the current tumor is consistent with a new primary in the opinion of the treating investigator
• Patients with bilateral synchronous RCCs are eligible if they can be resected or definitively treated at the same time or within a 12 week window from time of initial nephrectomy (partial or radical) or procedure and maintain adequate residual renal function; the patient is not eligible if both kidneys are completely removed and subsequent hemodialysis is required
• Permitted forms of local therapy for second tumor:
• Partial or radical nephrectomy
• If tumor is =< 3cm: thermal ablation (e.g., radiofrequency ablation, cryoablation or stereotactic radiosurgery)
• Patients cannot have concurrent malignancies, with the following exceptions:
• Adequately treated basal cell or squamous cell skin cancer
• In situ cervical cancer
• A history of superficial Ta urothelial cancer is permitted (as long as not currently undergoing treatment) whereas T1 or greater disease is excluded if < 3 years from diagnosis; concurrent persistent disease is not permitted
• Adequately treated stage I or II cancer from which the patient is currently in complete remission
• Any other cancer and stage from which the patient has been disease-free for at least 3 years prior to the time of pre-registration and as long as they are not receiving any current treatment (e.g. adjuvant or maintenance systemic or local therapy)
• Concurrent low risk prostate cancer on active surveillance
• No active known or suspected autoimmune disease; the following autoimmune disorders are permitted: patients with vitiligo, type I diabetes mellitus, controlled/stable hypothyroidism due to autoimmune or non-autoimmune conditions (hormone replacement is allowed), psoriasis not requiring systemic treatment, or other conditions not expected to recur
• No ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications with the exceptions outlined below; no treatment with other immunosuppressive agents within 14 days prior to the first dose of study drug with the following exceptions:
• Topical, ocular, intra-articular, intranasal, inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone or the equivalent are permitted in the absence of active autoimmune disease
• A brief (less than 3 weeks) course of corticosteroids (any amount) for prophylaxis (for example: contrast dye allergy) or for treatment of non-autoimmune conditions (for example: nausea, delayed-type hypersensitivity reaction caused by a contact allergen) is permitted
• No uncontrolled adrenal insufficiency
• No known chronic active liver disease or evidence of acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)
• No serious intercurrent illness, including ongoing or active infection requiring parenteral antibodies
• No known evidence of human immunodeficiency virus (HIV) infection, since the effects of nivolumab on anti-retroviral therapy have not been studied
• No known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results
• No major surgery within 28 days prior to randomization
• No patients currently enrolled in other clinical trials testing a therapeutic intervention
• No history of severe hypersensitivity to a monoclonal antibody
• Ability to understand and the willingness to sign a written informed consent document
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
• Patients must meet all Step 0 eligibility criteria at the time of their registration to Step 1
• In patients randomized to Arm H, core tumor biopsy must demonstrate RCC of any histology, including sarcomatoid, unclassified, or "unknown histology" (if preoperative biopsy was uninformative)
• NOTE: A non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator
• Women must not be pregnant or breast-feeding, as the effects of nivolumab on the developing human fetus or in the nursing infant are unknown; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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 (WOCBP) and males who are sexually active with WOCBP must use accepted and effective method(s) of contraception, or to abstain from sexual intercourse for the duration of their participation in the study; women of childbearing potential must use adequate methods to avoid pregnancy for 23 weeks after the last dose of nivolumab; sexually active males must use adequate methods to avoid pregnancy for 31 weeks after the last dose of nivolumab
• White blood cells >= 2000/uL (within 8 weeks of registration)
• Absolute neutrophil count (ANC) >= 1,500/mm^3 (within 8 weeks of registration)
• Platelet count >= 100,000/mm^3 (within 8 weeks of registration)
• Hemoglobin >= 9.0 g/dL (within 8 weeks of registration)
• Serum creatinine =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks of registration)
• Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks of registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 8 weeks of registration)
Procedure: Conventional Surgery, Biological: Nivolumab, Other: Patient Observation, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Metastatic Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Sarcomatoid Renal Cell Carcinoma, Unclassified Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7, Metastatic Malignant Neoplasm in Lymph Node, Metastatic Malignant Neoplasm in the Adrenal Gland, Metastatic Malignant Neoplasm in the Pancreas, Metastatic Malignant Neoplasm in the Skin, Metastatic Malignant Neoplasm in the Soft Tissues, Oligometastasis
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A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

Call 214-648-5005
studyfinder@utsouthwestern.edu
Amit Pandya
15504
All
18 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03715829
STU-2018-0447
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Inclusion Criteria:

• Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.
• Must have moderate to severe active non-segmental vitiligo.
Exclusion Criteria:

• History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
• Infected with hepatitis B or hepatitis C viruses.
• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Drug: PF-06651600, Drug: PF-06651600, Drug: PF-06651600, Drug: PF-06651600, Drug: PF-06651600, Drug: placebo, Drug: PF06700841, Device: narrow-band UVB phototherapy
Active Non-segmental Vitiligo
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Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea

This is a randomized, blinded, and controlled trial to assess the efficacy and safety of UVA1 phototherapy in the treatment of active morphea in adults and children. Forty patients will be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1 phototherapy) with an ultraviolet translucent acrylic screen or "sham" UVA1 (0 J/cm2) phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The phototherapists, patients, and principal investigator will be blinded to whether the patients receive active or sham UVA1 phototherapy. Patients will only be allowed to apply emollients during the study. Patients completing the randomized placebo controlled trial (RPCT) will be followed during an open observation period for 3 months. During the open phase, all outcome measures from the RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients who received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy using the same protocol as in the RPCT during the open observation. Adult patients enrolled in the RPCT will also be part of a nested translational study investigating the effect of UVA1 phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1) and after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in lesional skin before and after treatment as well as nonlesional skin.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Heidi Jacobe
54629
All
6 Years to 95 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01799174
STU 022012-025
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Inclusion Criteria:

• Presence of at least one active morphea lesion (linear, plaque, generalized, or mixed subtypes) confirmed by the primary investigator and/or by histopathological examination. Morphea lesions are clinically distinctive and therefore biopsy will only be performed if the diagnosis is in doubt.
• Age > 6 years at enrollment
• Male or female
• Patient or legal guardian must be able to speak and read English or Spanish at a 6th grade reading level. A translator will be available with additional consent forms in Spanish.
• Both male and female patients will be eligible
• All races and ethnic backgrounds will be included
• Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the study (if > 10 -17 years).
Exclusion Criteria:

• Age < 6 years at enrollment. (Patients under the age of 6 years will be excluded because study participants must be able to comply with the use of protective goggles and lie still during UVA1 phototherapy.)
• Presence of morphea profunda or eosinophilic fasciitis
• Contraindication to UVA1 phototherapy, including personal history of melanoma or non-melanoma skin cancer, history of photosensitive disorders (systemic lupus erythematosus, porphyrias, polymorphic light eruption, xeroderma pigmentosum, and the like), history of any type of organ transplant (solid organ or bone marrow).
• Current or <2 months prior use of systemic immunosuppressive therapy (methotrexate, prednisone mycophenolate mofetil, etc) or UVA1 phototherapy <2 months prior to enrollment.
• Prior failed UVA1 phototherapy (defined as requiring initiation of systemic therapy during or within 1 month of completion of prior course of UVA1 phototherapy).
• Presence of the following related to diagnosis of morphea: systemic manifestations (arthritis, uveitis, CNS changes, and the like), limited range of motion, contracture, limb length discrepancy requiring oral systemic therapy.
Procedure: UVA-1 Phototherapy, Procedure: Placebo
Scleroderma, Localized, Morphea, Scleroderma, Circumscribed
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Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study

Call 214-648-5005
studyfinder@utsouthwestern.edu
Lawrence Lavery
116716
All
18 Years to 89 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03843307
STU 042018-005
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Inclusion Criteria:

• Able to provide Informed Consent
• Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to therapy)
• Participant is a hospital in-patient for the duration of study procedures
• One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
• 18 years of age or older
Exclusion Criteria:

• Unable to provide informed consent
• <18 years of age
• Participant has a demand-type cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device.
• Participant has untreated osteomyelitis
• Participant has active cellulitis
• Participant has active charcot
• Is pregnant or plans to become pregnant
• Is nursing or actively lactating
• Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the participant's ability to provide informed consent, participate in the study protocol including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
Device: Avazzia Tennant Biomodulator® PRO
Perfusion, Complications, Wound, Foot
Electrical stimulation, Perfusion, Foot wound, Foot pain
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Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients (MP-10)

This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Karen Kowalske
14019
All
7 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02739464
STU 032015-065
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Inclusion Criteria:
1. Male and female subjects ≥7 to 60 years of age 2. >30% TBSA burned, as estimated by the physician in charge 3. No evidence of organ failure
Exclusion Criteria:
1. Active Tuberculosis- based on clinical symptoms and/or abnormal chest x-ray in the upper lobe. 2. Electrical burns 3. Mental retardation or autism or any other mental disorder that makes it impossible to participate in an exercise program 4. Pregnancy
Other: Exercise + SOC PT/OT, Other: SOC PT/OT
Muscle Weakness, Late Effect of Burn, Muscle, Fatigue, Heart, Burn Rehabilitation
Burn, Exercise, Ergometer, MP-10
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Protective Effects of Propranolol in Adults

This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Herbert Phelan
59840
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT01902810
STU 032013-008
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Inclusion Criteria:

• ≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
• Age ≥ 18 years
• Admission within 72 hours of injury
Exclusion Criteria:

• Age <18
• Patients unlikely to survive injury or with ;age = total burn size ≥ 130
• Electrical or deep chemical burn
• Malignancy currently undergoing treatment or history of cancer treatment within 5 years
• History of HIV or AIDS
• Presence of anoxic brain injury that is not expected to result in complete recovery
• Currently treated for Chronic Obstructive Pulmonary Disease (COPD), asthma or other chronic pulmonary conditions
• History of Congestive Heart Failure (CHF) (ejection fraction < 20%)
• Pre-injury medications including blocking agents (alpha or beta) or other anti-arrhythmic drugs
• Pregnant women
• Prisoners
• History of cardiac arrhythmia requiring medication
• Medical condition requiring glucocorticoid treatment
• Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
Drug: Propranolol, Drug: Placebo
Burn
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Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository (MAC)

The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically: - How morphea behaves over time - How frequently specific problems occur along with morphea (for example, arthritis) - Whether morphea has an autoimmune background
Call 214-648-5005
studyfinder@utsouthwestern.edu
Heidi Jacobe
54629
All
up to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT01808937
STU 112010-028
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Inclusion Criteria:
1. Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination. 2. Ages 0-90 years old 3. Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period. 4. Patient or legal guardian must be able to speak and read at a 6th grade reading level. 5. Both male and female patients will be eligible 6. All races and ethnic backgrounds will be included 7. Relationships to proband: All patients with morphea will be included. A patient's family history will be reviewed and if there is a family history of morphea or systemic sclerosis then we will give the study patient the investigator's contact information and ask the family member to call the study team to answer any questions and enroll them in the study if they choose to do so. 8. Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the morphea registry.
Exclusion Criteria:

•Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)
Other: Morphea
Scleroderma, Localized, Morphea, Scleroderma, Circumscribed, Frontal Linear Scleroderma en Coup de Sabre, Scleroderma, Linear
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