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IO-202 as Monotherapy in Patients in AML and CMML

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with relapsed or refractory monocytic AML and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D) and dose schedule as monotherapy.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Yazan Madanat
187698
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04372433
STU-2020-0961
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Inclusion Criteria:
1. Patients must be ≥18. 2. For the Part 1 Dose-Escalation Phase, patients must be diagnosed with the following: 1. Relapsed AML with myelomonocytic or monoblastic/monocytic differentiation according to the World Health Organization (WHO) 2016 criteria and has failed treatment with available therapies known to be active for AML. 2. CMML according to World Health Organization (WHO) 2016 criteria and has failed treatment with available therapies known to be active for CMML. 3. Part 2 Expansion Phase: a) AML with myelomonocytic or monoblastic/monocytic differentiation according to the World Health Organization 2016 criteria and has failed treatment with available therapies known to be active for AML. 4. Patients must be amenable to serial BM aspirates/biopsies and peripheral blood sampling during the study. 5. Patients must be able to understand and willing to sign an informed consent. A legally authorized representative may consent on behalf of a patient who is otherwise unable to provide informed consent, if acceptable to and approved by the site and/or site's Institutional Review Board (IRB) or Ethics Committee. 6. Patients must have an ECOG performance status of 0 to 2, inclusive. 7. Patients must have adequate hepatic function 8. Patients must have adequate renal function 9. Patients must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer (patients with residual Grade 1 toxicity, or any grade of alopecia, are allowed; patients with peripheral neuropathy that is not more than Grade 2 and stable are allowed). 10. Patients must be off calcineurin inhibitors (e.g., cyclosporine, tacrolimus) for at least 4 weeks prior to study drug treatment. 11. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy.
Exclusion Criteria:
1. Patients who have previously received IO-202. 2. Patients who have undergone HSCT within 60 days of the first dose of IO-202, or patients on immunosuppressive therapy post human stem cell transplantation (HSCT) at the time of screening, or with clinically significant graft-versus-host disease (GVHD) (the use of a stable dose of oral steroids post-HSCT of <10 mg prednisone/day or dose equivalent of other corticosteroid and/or topical steroids for ongoing skin GVHD is permitted with Medical Monitor approval). 3. Patients who received systemic anti-cancer therapy or radiotherapy <7 days prior to their first day of study drug administration (Hydroxyurea or leukapheresis is allowed up to 24 hours prior to the first dose. However, hydroxyurea must be ceased 24 hours prior to the first dose of IO-202 treatment in Cycle 1). 4. Patients who received an investigational agent <7 days prior to their first day of study drug administration. In addition, the first dose of IO-202 should not occur before a period ≥5 half-lives of the investigational agent has elapsed. 5. Patients for whom potentially curative anti-cancer therapy is available. 6. Patients who are pregnant or breast feeding. 7. Patients with uncontrolled, active infection. 8. Patients with known hypersensitivity to any of the components of the IO-202 formulation. 9. History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer that has been treated surgically with curative intent and presumed cured, resected breast cancer that has been treated with or is currently being treated with adjuvant hormonal and/or other endocrine therapy, resected prostate cancer that has been treated with androgen deprivation therapy and prostate-specific antigen level is stable or 0. 10. Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) or left ventricular ejection fraction (LVEF) <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan ≤28 days prior to Cycle 1, Day 1. 11. Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, clinically significant arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF (NYHA class III or IV), cerebrovascular accident, transient ischemic attack, or pulmonary embolism. Patients with asymptomatic right bundle branch block are allowed. 12. Ongoing cardiac dysrhythmias of NCI CTCAE, Version 5.0, Grade ≥2 or QT interval corrected by Fridericia's formula (QTcF) interval >470 msec at screening. 13. Known or suspected hypersensitivity to recombinant human proteins. 14. Active bacterial, viral, and/or fungal infection including hepatitis B (HB), hepatitis C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS)-related illness, or active Covid-19 infection. 15. Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry. 16. Patients with clinical signs and/or symptoms suggesting active, uncontrolled central nervous system (CNS) leukemia or known active, uncontrolled CNS leukemia (a lumbar puncture is not required in patients without signs or symptoms that are suggestive of CNS leukemia). Note: Patients with controlled CNS leukemia (documented by 2 consecutive assessments of zero blast count in cerebrospinal fluid), and who are still receiving intrathecal (IT) therapy at study entry are considered eligible and will continue to receive IT therapy. 17. Patients with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, or disseminated intravascular coagulation. 18. Patients known to be refractory to platelet or packed red cell transfusions per institutional guidelines. 19. Donor Lymphocyte Infusion within 30 days prior to first IO-202 administration. 20. Current active treatment in another interventional therapeutic clinical study. 21. Chronic systemic corticosteroid treatment with a dose of ≥10 mg prednisone/day or dose equivalent of another corticosteroid. Topical applications, inhaled sprays, eye drops, local injections of corticosteroids, and systemic steroids required for acute medical interventions are allowed. 22. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study. 23. Acute Promyelocytic Leukemia patients or patients with known Philadelphia chromosome (Ph+) positive AML or chronic myelogenous leukemia (CML) blast crisis. 24. Hyperleukocytosis (leukocytes ≥25 x 10e9/L) at first dose of IO-202. These patients may be treated with hydroxyurea or receive leukapheresis treatment according to routine practice, and enrolled in the study when the leukocyte count falls below 25 x 10e9/L. 25. Patients who are investigational site staff members or relatives of those site staff members or patients who are Immune-Onc employees directly involved in the conduct of the trial.
Drug: IO-202 Dose Escalation, Drug: IO-202 Dose Expansion
Leukemia, Other, AML M5, AML M4, AML, Nos, Acute Myelogenous Leukemia in Relapse, Myelomonocytic Leukemia, Chronic
Monocytic, Myelomonocytic
UT Southwestern
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REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

The primary objective of the dose escalation (phase 1) part of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered Non-small cell lung cancer (NSCLC). The primary objective of the dose expansion (phase 2) part of the study is to assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Sawsan Rashdan
171142
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04077099
STU-2019-1756
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Key
Inclusion Criteria:

• Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patients must have exhausted all approved available therapies appropriate for the patient.
• Has available archival tumor tissue, unless discussed with the medical monitor.
• Willing to provide tumor tissue from newly obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed with the medical monitor. For patients in expansion cohorts, biopsies should be taken from tumor site which has not been irradiated previously and is not the only measurable target lesion.
• Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression, as defined in the protocol. Key
Exclusion Criteria:

• Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks or 5 half-lives of the prior treatment whichever is shorter with a minimum of 7 days from the first dose of study therapy
• Has not yet recovered (i.e. grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
• Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. grade ≤1 or baseline) from AEs, except for laboratory changes as described in the protocol and patients with grade ≤2 neuropathy
• For expansion cohorts only: prior treatment with MET-targeted biologic therapy (function-blocking antibodies or ADCs)
• For expansion cohorts only (except cohort 1A) prior treatment with any MET-targeted agent including small molecule tyrosine kinase inhibitors eg, crizotinib, capmatinib, tepotinib, as defined in the protocol
• Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol Note: Other protocol defined Inclusion/Exclusion criteria apply.
Drug: REGN5093
NSCLC, Lung/Thoracic
MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease
UT Southwestern
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Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

This trial studies the side effects of radiation therapy followed by atezolizumab in treating patients with stage II or III non-small cell lung cancer. Hyperfractionated radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to test the safety and effectiveness of radiation therapy followed by atezolizumab and find out what side effects, if any, it has on patient's non-small cell lung cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Suzanne Cole
42296
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04310020
STU-2021-0049
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Inclusion Criteria:

• REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC)
• REGISTRATION STEP 1: Participants must have stage III NSCLC with Zubrod performance status of 2 or stage II NSCLC with Zubrod performance status of 0-2
• REGISTRATION STEP 1: Participants must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection
• REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator
• REGISTRATION STEP 1: Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
• REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1
• REGISTRATION STEP 1: Participants' disease must fit within the radiation constraints in the opinion of a local radiation oncologist
• REGISTRATION STEP 1: Participants may have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment
• REGISTRATION STEP 1: Participants may have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study
• REGISTRATION STEP 1: Participants must have recovered from any adverse effects of prior major surgery to the satisfaction of the treating physician. Biopsies and central IV access placement are not considered major surgery
• REGISTRATION STEP 1: Absolute neutrophil count (ANC) >= 1500/mcl (obtained within 28 days prior to Registration Step 1)
• REGISTRATION STEP 1: Platelet count >= 100,000/mcl (obtained within 28 days prior to Registration Step 1)
• REGISTRATION STEP 1: Hemoglobin >= 9 grams/dL (obtained within 28 days prior to Registration Step 1)
• REGISTRATION STEP 1: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 1)
• REGISTRATION STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (obtained within 28 days prior to Registration Step 1)
• REGISTRATION STEP 1: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min (obtained within 28 days prior to Registration Step 1)
• REGISTRATION STEP 1: Participants must have percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 50% documented within 90 days prior to Registration Step 1
• REGISTRATION STEP 1: Patient must not have had a prior history of interstitial lung disease or > grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5) pneumonitis
• REGISTRATION STEP 1: Participants must not have active autoimmune disease requiring therapy within the past 6 months
• REGISTRATION STEP 1: Participants must not have an active infection requiring therapy
• REGISTRATION STEP 1: Participants must not be pregnant or nursing because atezolizumab has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. Women/men of reproductive potential must have agreed to use an effective contraceptive method while on protocol treatment and for five months after last dose of atezolizumab. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• REGISTRATION STEP 1: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Registration Step 1
• REGISTRATION STEP 1: Patient must be tested for hepatitis B within 28 days prior to Registration Step 1. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection. Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test. Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test
• REGISTRATION STEP 1: Patients must not have active hepatitis C virus (HCV) infection. Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test. Patient must have an HCV antibody test within 28 days prior to Registration Step 1. If the HCV antibody test is positive, the patient must also have an HCV quantitative RNA test within 28 days prior to Registration Step 1
• REGISTRATION STEP 1: 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, or any other cancer from which the patient has been disease free for three years. Participants with localized prostate cancer who are being followed by an active surveillance program are also eligible
• REGISTRATION STEP 1: Participants must be offered optional participation in banking of specimens for future research
• REGISTRATION STEP 1: Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• REGISTRATION STEP 1: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• REGISTRATION STEP 2: Participants must be registered to Step 2 within 42 days after completion of radiation treatment. Participants must have received at least 44 Gy of radiation treatment
• REGISTRATION STEP 2: Participants must have no evidence of progression per RECIST 1.1 on CT scan of the chest, abdomen, and pelvis performed between 2 and 5 weeks after completion of radiation therapy
• REGISTRATION STEP 2: Any toxicities from radiation therapy must have resolved to < grade 2
• REGISTRATION STEP 2: Absolute neutrophil count (ANC) >= 1500/mcl (obtained within 28 days prior to Registration Step 2)
• REGISTRATION STEP 2: Platelet count >= 100,000/mcl (obtained within 28 days prior to Registration Step 2)
• REGISTRATION STEP 2: Hemoglobin >= 9 grams/dL (obtained within 28 days prior to Registration Step 2)
• REGISTRATION STEP 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 2)
• REGISTRATION STEP 2: AST and ALT =< 2.5 x IULN (obtained within 28 days prior to Registration Step 2)
• REGISTRATION STEP 2: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min (obtained within 28 days prior to Registration Step 2)
• REGISTRATION STEP 2: Participants must not have received steroids in doses of more than prednisone 10 mg daily or equivalent within 14 days prior to Registration Step 2
• REGISTRATION STEP 2: Participants must not have received a live vaccine within 28 days prior to Registration Step 2
Drug: Atezolizumab, Radiation: Hypofractionated Radiation Therapy
Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Unresectable Lung Non-Small Cell Carcinoma
UT Southwestern; Parkland Health & Hospital System
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Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma

Magnetic Resonance Imaging (MRI) including Arterial Spin Labeling (ASL) will be performed before, during, and after the treatment, in a total of up to 6 MRI sessions until 7 months after the first session, or when progression is clinically indicated. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first. Clinically, metastatic renal cell carcinoma (RCC) patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy, since morphological (i.e. size) changes are not anticipated earlier. However, our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment. T0, T1, and T2 sessions will be performed for this proposal, while T3, T4, and T5 will be performed along with the clinical imaging sessions. All MR imaging sessions will be scheduled within ±1 or ±2 weeks of the target time period. The research MR imaging may take approximately an additional 15 minutes per each imaging session, when done in conjunction with the clinical imaging. The T0, T1, and T2 research MR imaging sessions will be performed additionally for the purpose of this study, with each taking approximately one hour.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Ananth Madhuranthakam
131918
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04831138
STU 032018-078
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Inclusion Criteria:

• Patients with locally advanced or metastatic renal cell carcinoma.
• Patients scheduled to undergo anti-angiogenic treatment or immunotherapy
• Eastern Cooperative Oncology Group (ECOG) Status 0, 1 and 2.
• Women of child-bearing potential must agree to undergo a urine pregnancy screening per standard Radiology departmental protocol, in place to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:

• Subjects may not be receiving any other anti-angiogenic agents, at the time of enrollment.
• Subjects must not be pregnant since pregnancy is a contraindication to administration of gadolinium-based contrast agents.
• Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices (e.g. pacemakers, automated implantable cardioverter defibrillators, etc.) and other foreign bodies.
• Known severe allergic reaction to Gadolinium-based contrast agents.
• Patients with sickle cell disease and patients with other hemolytic anemias (low red blood count in body).
• Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study.
Procedure: MRI with ASL
Renal Cell Carcinoma, Kidney
magnetic resonance imaging, arterial spin labeling
UT Southwestern
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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer (ASCLEPIuS)

The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Neil Desai
161725
Male
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04194554
STU-2020-1203
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Inclusion Criteria 1. Pathologic biopsy proven adenocarcinoma of the prostate 2. At least one of the following criteria:
• cN1 on conventional or PET imaging
• Grade group 5
• Grade group 4 and PSA ≥10 ng/mL
• Grade group 3 and PSA ≥20 ng/mL
• High probability of Radiographic T3 on MRI AND Grade group ≥2
• Grade Group 3 AND PSA ≥10 ng/mL AND ≥50% positive biopsy cores 3. Age ≥ 18 4. ECOG < 1 5. Adequate organ and marrow function as defined per protocol. 6. Use of highly effective contraception (e.g. condoms) for the duration of treatment and a minimum of 90 days thereafter. Men must also agree not to donate sperm for the duration of the study participation, and for at least 90 days thereafter. 7. International Prostate Symptoms Score (IPSS) ≤ 20 8. Medically fit for treatment and agreeable to follow-up 9. Ability to understand and the willingness to sign a written informed consent 10. Tissue available for MiOncoSeq testing to assign DNA repair deficiency status Exclusion Criteria 1. Clinical or radiographic evidence of distant metastatic disease by CT/bone scan 2. Clinical or radiographic evidence of high probability of clinical T4 disease 3. Prostate gland size >80 cc measured by ultrasound or MRI 4. Prominent median lobe assessed by treating physician 5. Lack of tissue from biopsy to be sent for correlative studies 6. Any prior treatment for prostate cancer (incudes TURP, chemotherapy, radiation therapy, or anti-androgen therapy) 7. Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies. 8. Prohibited 3 months before participant registration and during administration of study treatment: non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide), steroidal antiandrogens (megestrol acetate, cyproterone acetate), oral ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals. 9. History of prior pelvic radiation therapy 10. Concurrent treatment with strong CYP3A4 inducers such as phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital 11. Enrollment concurrently in another investigational drug study within 1 month of registration 12. History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer 13. History of or active Crohn's disease or ulcerative colitis 14. Contraindication to or inability to tolerate MRIs 15. Patients with severe depression 16. Uncontrolled diabetes or known HbA1c>10 17. Any gastrointestinal disorder affecting absorption 18. Active pituitary or adrenal dysfunction 19. Patients with significant cardiovascular disease potentially including severe / unstable angina, recent history of myocardial infarction, clinically significant heart failure, cerebrovascular disease, venous thromboembolic events, clinically significant arrhythmias) 20. Uncontrolled hypertension with persistently elevated systolic blood pressure >160 mmgHg or diastolic blood pressure >100 mmHg despite anti-hypertensive agents. 21. Prolonged QTc >450 ms or any ECG changes that interfere with QT interval interpretation 22. Major surgery within 1 month of registration 23. History of myelodysplastic syndrome or leukemia 24. A known hypersensitivity to niraparib, abiraterone acetate, leuprolide, and/or prednisone 25. Active infection or other medical condition that would be a contraindication to prednisone use 26. Patients with known active hepatitis or chronic liver disease including cirrhosis 27. Any condition that in the opinion of the investigator would preclude participation in this study
Drug: Niraparib, Drug: Leuprolide, Drug: Abiraterone Acetate, Radiation: Stereotactic body radiotherapy (SBRT)
Prostate Cancer, Prostate
UT Southwestern
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Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

There is a high rate of intravesical (bladder) recurrence following extirpative surgery for upper tract urothelial carcinoma. There is no single established standard of care for prevention of intravesical recurrence; however, one protocol in common use involves the use of intravesical gemcitabine instilled into the bladder during surgery and prior to entry into the bladder. There are barriers to the use of gemcitabine, especially at lower volume centers. Some evidence suggests that intravesical irrigation with sterile water has equivalent efficacy to intravesical chemotherapy in prevention of recurrent bladder cancer following transurethral resection of bladder tumors (TURBT). This study is intended to compare recurrence rates using intravesical gemcitabine (as a pseudo-standard of care) and continuous bladder irrigation with sterile water.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Yair Lotan
59883
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04865939
STU-2021-0402
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Inclusion Criteria:

• Biopsy proven UTUC with plan for excisional surgery (distal ureterectomy or nephroureterectomy) with curative intent
• Age 18
•90 years
• Life expectancy > 1 year
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Female participants who become pregnant or who suspect that they are pregnant should notify the treating investigator immediately.
• Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:

• Concurrent or prior diagnosis of bladder cancer with a disease-free interval of less than three years.
• Synchronous bilateral upper tract urothelial carcinoma (prior history of contralateral UTUC is permissible with a disease-free interval of more than three years).
• Plan for radical cystectomy.
• 3.2.4 Suspicion for small bladder capacity (< 100 mL) based on treating urologist's clinical judgment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.
Procedure: sterile water irrigation, Drug: Gemcitabine
Urinary Bladder, Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma Ureter
UT Southwestern
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Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial (PROBE)

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Suzanne Cole
42296
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04510597
STU-2021-0266
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Inclusion Criteria:

• STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible
• STEP 1 REGISTRATION: Participants must have primary tumor in place
• STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:
• Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)
• CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast Scans must be performed within the following timeframes:
• Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration
• Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment
• STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration
• STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy
• STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
• STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
• STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment
• CT scan of the chest (can be performed without contrast if CT contrast cannot be given)
• CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2 • STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment
• Stable disease
• Partial response
• The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1
• STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment
• STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy
• STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:
• 2 infusions of nivolumab + 1 infusion of ipilimumab
• 2 infusions of pembrolizumab
• 2 infusions of avelumab
• STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization
• STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization
• STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization
• STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization
• STEP 2 REGISTRATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to randomization)
• STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
• STEP 2 REGISTRATION: Serum creatinine =< 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)
Exclusion Criteria:

• STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
• STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:
• Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy
• Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment
• STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:
• Treatment naive participants must not have received any pre-randomization treatment.
• Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:
• 4 infusions of nivolumab
• 4 infusions of ipilimumab
• 4 infusions of pembrolizumab
• 7 infusions of avelumab
• STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:
• Treatment naive participants must not have received any immunotherapy within a year of registration
• Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment
• STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney
• STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years
• STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy
• STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed
• STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
• STEP 2 REGISTRATION: 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 participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
Procedure: Cytoreductive Nephrectomy, Drug: Active Comparator
Metastatic Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Kidney
UT Southwestern
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Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Brooke.Piskator@UTSouthwestern.edu
Brett Johnson
172791
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04519294
STU-2020-1034
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Inclusion Criteria:

• Candidate for ureteroscopy with laser lithotripsy;
• Presence of renal stone(s);
• Be willing and able to return for all study-related follow up procedures; and,
• Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.
Exclusion Criteria:

• BMI > 45;
• Significant comorbidities;
• Bladder, ureteral or kidney abnormalities;
• Pregnant individuals; or
• Unable to meet the treatment and follow up protocol requirements.
Device: SURE, Device: Standard Ureteroscopy (Basketing)
Kidney Stone, Kidney, Renal Stone, Urolithiasis
UT Southwestern
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Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST3)

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Lauren.Kerich@UTSouthwestern.edu
Ahamed Idris
58880
All
14 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03754114
STU-2019-0560
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Inclusion Criteria:

• Non-penetrating traumatic brain injury
• Glasgow Coma Scale (GCS) 3-8 measured off paralytics
• Glasgow Coma Scale motor score < 6 if endotracheally intubated
• Evidence of intracranial trauma on CT scan
• Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
• Able to place intracranial probes and randomize within 12 hours from injury
• Age greater than or equal to 14 years
Exclusion Criteria:

• Non-survivable injury
• Bilaterally absent pupillary response in the absence of paralytic medication
• Contraindication to the placement of intracranial probes
• Treatment of brain tissue oxygen values prior to randomization
• Planned use of devices which may unblind treating physicians to brain tissue hypoxia
• Systemic sepsis at screening
• Refractory hypotension
• Refractory systemic hypoxia
• PaO2/FiO2 ratio < 200
• Known pre-existing neurologic disease with confounding residual neurological deficits
• Known inability to perform activities of daily living (ADL) without assistance prior to injury
• Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
• Pregnancy
• Prisoner
• On EFIC Opt-Out list as indicated by a bracelet or medical alert
Other: ICP + PbtO2 guided management strategy, Other: ICP guided management strategy
Brain Injuries, Traumatic
intracranial pressure, hypoxia, brain, critical care, emergency treatment, monitoring, physiologic
Parkland Health & Hospital System
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Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15)

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Waddah Arafat
183526
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04700124
STU-2021-0055
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Inclusion Criteria:

• Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology
• Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
• Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have adequate organ function
Exclusion Criteria:

• Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
• Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC
•prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
• Has ≥N2 disease or metastatic disease (M1) as identified by imaging
• Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
• Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
• Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
• Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
• Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
• Has a known psychiatric or substance abuse disorder
• Has had an allogenic tissue/solid organ transplant
• Has ongoing sensory or motor neuropathy Grade 2 or higher
• Has active keratitis (superficial punctate keratitis) or corneal ulcerations
• Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms
Biological: Pembrolizumab, Biological: Enfortumab vedotin (EV), Procedure: RC + PLND, Drug: Gemcitabine, Drug: Cisplatin
Muscle Invasive Bladder Cancer
Programmed cell death 1 (PD-1), Programmed Death-Ligand 1 (PD-L1), Programmed Death-Ligand 2 (PD-L2), Pelvic Lymph Node Dissection (PLND), Radical Cystectomy (RC)
UT Southwestern
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A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Call 214-648-5005
studyfinder@utsouthwestern.edu, tatyana.ganz@utsouthwestern.edu
Kelly Chin
38273
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04712669
STU-2021-0371
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Inclusion Criteria:
1. Male and female 18 years or older 2. Body Mass Index (BMI) >18kg/m2 to <=40kg/m2 3. Symptomatic PAH belonging to one of the following 2018 WHO Clinical Group 1 subtypes: a. Idiopathic PAH b. Heritable PAH c. Drug- or toxin-induced d. PAH associated with: 1. Connective tissue disease 2. Congenital systemic to pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) repaired at least one year prior to Screening 3. Human immunodeficiency virus (HIV) infection
•if diagnosed with HIV, must have stable disease status defined as follows: 1. stable treatment with HIV medications for at least 8 weeks prior to Screening 2. no active opportunistic infection during the Screening Period 3. no hospitalizations due to HIV for at least 4 weeks prior to Screening 4. WHO FC II or III 5. Confirmed diagnosis of PAH and meet all the following hemodynamic criteria by means of a screening RHC completed prior to randomization: 1. mPAP of >20 mmHg 2. PVR ≥ 350 dyne•sec/cm5 3. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 350 and < 500 dyne•sec/cm5, or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dyne•sec/cm5 6. 6MWD of 100 to 550 meters at Screening 7. Currently on a stable treatment regimen with one or more treatments approved for PAH. Stable therapy is defined as receiving the same medication(s) for ≥ 12 weeks prior to the screening RHC and at a stable dose level for each for ≥ 8 weeks prior to the screening RHC (see Protocol Section 6.6.2 for approved PAH medications). Any instances where doses of a medication have been missed prior to RHC must be discussed with the Medical Monitor prior to performing the RHC. 8. Meet all of the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to Screening (performed with or without bronchodilation): 1. Forced expiratory volume in one second (FEV1) ≥ 60% of predicted normal, and 2. Total lung capacity (TLC) ≥ 70% of predicted normal or FVC ≥ 70% predicted if TLC is not available; For subjects with CTD associated PAH, if TLC is ≥ 60% of predicted but < 70% of predicted of if FVC ≥ 60% or predicted but < 70% of predicted, high resolution computed tomography [HRCT] obtained within 6 months of screening may be utilized to demonstrate limited interstitial lung disease 9. If participating in an exercise program for pulmonary rehabilitation, the program must have been initiated ≥ 12 weeks prior to Screening, and patient must agree to maintain the current level of rehabilitation for the first 24 weeks of receiving IP. If not participating in an exercise training program for pulmonary rehabilitation, patient must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 24 weeks of receiving IP.
Exclusion Criteria:
1. Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception 2. WHO pulmonary hypertension (PH) Group 1 PAH associated with portal hypertension or schistosomiasis; PH due to left heart disease (WHO PH Group 2), lung diseases and/or hypoxia (WHO PH Group 3), chronic thromboembolic PH (WHO PH Group 4), or PH with unclear multifactorial mechanisms (WHO PH Group 5) 3. PH associated with significant venous or capillary involvement (PCWP > 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD) 4. Three or more of the following risk factors for left ventricular disease: 1. BMI > 30 kg/m2 2. Diagnosis of essential hypertension that is actively treated 3. Diabetes mellitus 4. History of significant coronary artery disease (e.g., chronic stable angina, history of coronary intervention within the last 3 months, or a stenosis > 70% at coronary angiography) 5. Atrial fibrillation 6. Left atrial volume index > 41 mL/m2 [or left atrial diameter (LA) > 4 cm if LAVi unavailable] 5. Known genetic hypertrophic cardiomyopathy 6. Known cardiac sarcoidosis or amyloidosis 7. The patient has a history of, or currently has, a constrictive cardiomyopathy. 8. Known history of any left ventricular ejection fraction (LVEF) < 40% by echocardiogram within 3 years of randomization (Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition [e.g., atrial fibrillation] is allowed). 9. Hemodynamically significant valvular heart disease as determined by the Investigator, including: 1. greater than mild aortic and/or mitral stenosis and/or 2. severe mitral and/or aortic regurgitation (> Grade 3) 10. Severe arthritis, musculoskeletal problems, or morbid obesity that, in the opinion of the Investigator, is the cause of the patient's functional limitation and would affect the patient's ability to perform or complete the 6MWT.
Drug: rodatristat ethyl 300 mg tablet BID, Drug: rodatristat ethyl 600 mg BID, Drug: Placebo
Pulmonary Arterial Hypertension, Cardiovascular
PAH
UT Southwestern
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Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)

The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Orhan Oz
15477
Male
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04647526
STU-2021-0009
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Inclusion Criteria:
1. Male aged 18 years or older. 2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 3. Ineligible or averse to chemotherapeutic treatment options. 4. Patients must have progressive mCRPC at the time of consent based on at least 1 of the following criteria: 1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart. 2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion. 3. Progression of bone disease defined as the appearance of two or more new lesions by bone scan. 5. Progression on previous treatment with one ARAT (abiraterone or enzalutamide or darolutamide or apalutamide) in either the CSPC or CRPC setting. 6. PSMA-PET scan (i.e., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by the sponsor's central reader. 7. Castrate circulating testosterone levels (<1.7 nmol/L or <50 ng/dL). 8. Adequate organ function, independent of transfusion: a. Bone marrow reserve: i. White blood cell (WBC) count ≥2.5 × 10^9/L OR absolute neutrophil count (ANC) ≥1.5 × 10^9/L. ii. Platelets ≥100 × 10^9/L. iii. Hemoglobin ≥8 mmol/L. b. Liver function: i. Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome, ≤3 × ULN is permitted. ii. ALT or AST ≤3.0× ULN. c. Renal function: i. Serum/plasma creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula (for patients in France, serum/plasma creatinine ≤1.5 × ULN or CrCl ≥60 mL/min based on Cockcroft-Gault formula). d. Albumin ≥30 g/L. 9. Human immunodeficiency virus-infected patients who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are included in this trial. 10. For patients who have partners who are pregnant or of childbearing potential: a condom is required along with a highly effective contraceptive method during the study and for 6 months after last study drug administration. Such methods deemed highly effective include a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, b) progestogen-only hormonal contraception associated with inhibition of ovulation, c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f) vasectomy, g) true sexual abstinence: when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of abstinence]. 11. Willing to initiate ARAT therapy (either enzalutamide or abiraterone), pre-specified by investigator, if randomized to Treatment Arm B. 12. ECOG performance status 0 to 1. 13. Willing and able to comply with all study requirements and treatments (including 177Lu PNT2002) as well as the timing and nature of required assessments. 14. Signed informed consent.
Exclusion Criteria:
Patients are excluded from the study if any of the following criteria apply: 1. If noted in pathology report, prostate cancer with known significant (>10% present in cells) sarcomatoid or spindle cell or neuroendocrine components. Any small cell component in the cancer should result in exclusion. 2. Prior treatment for prostate cancer ≤28 days prior to randomization, with the exclusion of first-line local external beam, ARAT, luteinizing hormone-releasing hormone (LHRH) therapy, or non-radioactive bone-targeted agents. 3. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel); chemotherapy for hormone-sensitive prostate cancer (HSPC) is allowed if the last dose was administered >1 year prior to consent. 4. Prior treatment with systemic radionuclides (e.g. radium-223, rhenium-186, strontium 89). 5. Prior immuno-therapy, except for sipuleucel-T. 6. Prior PSMA-targeted radioligand therapy, e.g., Lu-177-PSMA-617, I 131-1095. 7. Prior poly ADP ribose polymerase (PARP) inhibitor for prostate cancer. 8. Patients who progressed on 2 or more lines of ARATs. 9. Patients receiving bone-targeted therapy (e.g. denosumab, zoledronic acid) not on stable doses for at least 4 weeks prior to randomization. 10. Administration of an investigational agent ≤60 days or 5 half-lives, whichever is shorter, prior to randomization. 11. Major surgery ≤30 days prior to randomization. 12. Estimated life expectancy <6 months as assessed by the principal investigator. 13. Presence of liver metastases >1 cm on abdominal imaging. 14. A superscan on bone scan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity. 15. Dose escalation or initiation of opioids for cancer-related pain ≤30 days prior to consent up to and including randomization. 16. Known presence of central nervous system metastases. 17. Contraindications to the use of planned ARAT therapy, [Ga-68]-PSMA-11, [F-18]-DCFPyL or [Lu-177]-PNT2002 therapy, including but not limited to the following:
• Hypersensitivity to [Ga-68]-PSMA-11, [F-18]-DCFPyL or [Lu-177]-PNT2002 excipients (Diethylenetriaminepentaacetic acid (DTPA), Sodium ascorbate, Lascorbic acid, Sodium gentisate, HCl, Sodium hydroxide).
• Recent myocardial infarction or arterial thrombotic events (in the past 6 months) or unstable angina (in the past 3 months), bradycardia or left ventricular ejection fraction measurement of < 50%.
• History of seizures in patients planned to receive enzalutamide. 18. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer. 19. Concurrent illness that may jeopardize the patient's ability to undergo study procedures. 20. Serious psychological, familial, sociological, or geographical condition that might hamper compliance with the study protocol and follow-up schedule. Patients that travel need to be capable of repeated visits even if they are on the control arm. 21. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 22. Concurrent serious (as determined by the investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure (see 12.1 Appendix 1), unstable ischemia, uncontrolled symptomatic arrhythmia, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
Drug: [Lu-177]-PNT2002, Drug: Abiraterone, Drug: Enzalutamide
Prostate, Metastatic Castration-resistant Prostate Cancer
PSMA, mCRPC, Prostate cancer, 177Lu-PSMA, radioligand therapy, PSMA-I&T, SPLASH
UT Southwestern
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Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: A Pilot Study

The purpose of this prospective pilot study is to determine if live music therapy reduces patients' perception of pain and anxiety, reduces benzodiazepine use and pain medication use, length of stay in the ICU, and length of stay in hospital, and improves sleep in post-lung transplant patients. The purpose and objectives of the study are the following: - To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived anxiety in post-lung transplant patients. - To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived pain in post-lung transplant patients. - To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's use of benzodiazepine medication for anxiety. - To determine if music therapist delivered patient preferred live music and therapeutic intervention three times in post-lung transplant patients will reduce participant's use of pain medication. - To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's total time of intubation, length of stay in ICU, and length of stay in the hospital. - To determine if music therapist delivered patient preferred live music and therapeutic intervention will improve the quality and length of sleep in post-lung transplant patients.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Teresa.Phan@UTSouthwestern.edu
Emily Pickett
125393
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04975607
STU-2019-1409
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Inclusion Criteria:

• All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021
Exclusion Criteria:

• Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)
Behavioral: Music Therapy
Cardiovascular, Lung Transplant, Complications
UT Southwestern
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Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS)

The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: - To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE - To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation - To study the effects of dupilumab on the type 2 inflammation gene expression signature - To evaluate the concentration-time profile of functional dupilumab in serum in this population - To assess efficacy of long-term (52 weeks) dupilumab treatment - To assess safety, tolerability, and immunogenicity of long-term (52 weeks) dupilumab treatment - To evaluate the impact of dupilumab treatment on EoE signs and symptoms
Call 214-648-5005
studyfinder@utsouthwestern.edu, Kaylee.Lirely@Childrens.com
Christopher Parrish
168280
All
1 Year to 11 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04394351
STU-2020-1291
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Key
Inclusion Criteria:

• A documented diagnosis of eosinophilic esophagitis (EoE)
• Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration Key
Exclusion Criteria:

• Body weight <5 kg or ≥60 kg at screening
• Other causes of esophageal eosinophilia
• Active Helicobacter pylori
• History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
• Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
• Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
• History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure
• Active parasitic infection or suspected parasitic infection
• Known or suspected immunodeficiency disorder NOTE: Other protocol defined inclusion/exclusion criteria apply.
Drug: Dupilumab, Drug: Matching Placebo
Esophagus, Eosinophilic Esophagitis (EoE)
Children’s Health
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FT516 in Subjects With Advanced Hematologic Malignancies

This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Farrukh Awan
180091
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04023071
STU-2020-1273
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KEY INCLUSION CRITERIA: Diagnosis of the following: Regimen A (FT516 monotherapy):
• Primary Refractory AML
• Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required Regimen B (FT516 + rituximab or obinutuzumab):
• Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival. All subjects:
• Provision of signed and dated informed consent form (ICF)
• Age ≥18 years old
• Stated willingness to comply with study procedures and duration
• Presence of measurable disease KEY EXCLUSION CRITERIA: All subjects:
• Females of reproductive potential who are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
• Evidence of insufficient organ function
• Receipt of therapy within 2 weeks prior to Cycle 1 Day 1 or within five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1
• Currently receiving or likely to require systemic immunosuppressive therapy
• Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy
• Receipt of an allograft organ transplant
• Known active central nervous system (CNS) involvement by malignancy.
• Clinically significant cardiovascular disease
• Clinically significant infections including: Known HIV infection; Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
• Live vaccine <6 weeks prior to start of lympho-conditioning
• Known allergy to human albumin and DMSO Additional Exclusion Criteria for FT516 monotherapy Regimen: Diagnosis of promyelocytic leukemia with t(15:17) translocation Additional Exclusion Criteria for FT516 plus monoclonal antibody Regimens: Diagnosis of Waldenstrom macroglobulinemia
Drug: FT516, Drug: Rituximab, Drug: Obinutuzumab, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: IL-2, Drug: Bendamustine
Acute Myelogenous Leukemia, Lymphoid Leukemia, Non-Hodgkins Lymphoma, B-cell Lymphoma
AML, Lymphoma
UT Southwestern
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Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

The study team will be performing a study comparing the use of Heparin Flushes vs. Normal Saline Flushes in making sure central lines stay open. The participants will be placed in a group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care (control group) for maintaining central lines, or a group to receive Normal Saline Flushes only (experimental group) to keep their central line open. The participants electronic medical record will be reviewed by study team members for the inclusion/exclusion criteria, the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and they may be asked questions regarding their medical history during their stay on 11 Blue BMT. If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no longer be included in the study and their central line maintenance will return to the UTSW Standard of Care. Participants in this study may be at risk for central line occlusion (a blood clot) which could require intervention to regain the free flow of fluids and use of the central line. The study team predicts there will be no increase in the rate of line occlusion when using Normal Saline Flushes only to maintain the free flow of fluids through participants central line. The study team also hopes the results of this study will help to improve patient outcomes by decreasing risk of infection, heparin associated complications, and costs.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Meredith Allen
157061
All
18 Years to 80 Years old
Early Phase 1
This study is also accepting healthy volunteers
NCT05029596
STU-2018-0340
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Inclusion Criteria:

• Oncology patients
• Admitted to 11Blue Bone Marrow Transplant Unit at Clements University Hospital University of Texas Southwestern Medical Center
• Ages 18-80 years
• Pre-existing or newly placed PICC line
• PICC line with good blood return (defined as: "brisk blood return of 3cc")
• Flushes without difficulty
Exclusion Criteria:

• Patient less than 18 years of age or greater than 80 years of age
• Refused or unable to give consent to the study
• Patient admitted to the 11Blue BMT unit with any line other than a PICC line, or multiple lines
• Patient admitted to 11Blue BMT for active transplant
• Patient with a coagulopathy diagnosis
• Patient on therapeutic dose of anticoagulants for documented Deep Vein Thrombosis or Pulmonary Embolism
• Patient on inpatient hospice/comfort care
• Patient transferred off 11B BMT unit onto another floor
Drug: Normal Saline Group, Drug: Heparin Group
Lymphoma, Cancer, Multiple Myeloma, Leukemia, Other, Leukemia, Not Otherwise Specified, Lymphoid Leukemia, Myeloid and Monocytic Leukemia
Peripherally Inserted Central Lines, Heparin Flush
UT Southwestern
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Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Vitaly Margulis
49444
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04628767
STU-2021-0698
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Inclusion Criteria:

• STEP 1 REGISTRATION AND RANDOMIZATION
• Patients must be >= 18 years of age
• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
• Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following:
• Upper urinary tract mass on cross-sectional imaging or
• Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology
• NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice
• Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration/randomization)
• Platelets >= 100,000/mcL (obtained =< 14 days prior to registration/randomization)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration/randomization)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 14 days prior to registration/randomization)
• Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization)
• NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial
• NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
• NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of registration/randomization
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
• Patient must have a body weight of > 30 kg
• Patient must have life expectancy of >= 12 weeks
• Patient must have creatinine clearance > 15 ml/min as by Crockroft-Gault formula or 24-hour creatinine clearance within 28 days prior to registration/randomization
• NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and/or hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B
• Patients that meet any of the following criteria will be registered and assigned to the cisplatin-ineligible Arm C if they meet other eligibility criteria:
• Creatinine clearance > 15 ml/min and =< 50 ml/min or hearing loss grade >= 3, or neuropathy >= 2, or ECOG PS 2
• Patient must have an absolute neutrophil count (ANC) >= 1,000/mcL obtained =< 14 days prior to registration
• Patient must have ECOG performance status 0-2
• Patients that meet the following criteria will be randomized to the cisplatin-eligible Arm A or Arm B:
• Patient must have creatinine clearance of > 50ml/min, PS ECOG 0-1, absence of hearing loss grade >= 3, and/or neuropathy >= 2
• Patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization
• Patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization
Exclusion Criteria:

• Patients must not have any component of small cell/neuroendocrine carcinoma. Other variant histologic types are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma
• Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, 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 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
• Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings >=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) or other imaging or other criteria can be eligible based on investigator discretion).
• NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scans to evaluate for bone metastasis at the discretion of local provider.
• Patient must meet below criteria for prior/current malignancy history:
• Non-urothelial cancer malignancy history:
• Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
• NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed
• Urothelial cancer malignancy history:
• Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
• T0, Ta or Tis at any time
• T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy [e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)]. Prior immune checkpoint inhibitor is not allowed.
• Patient with history of >= pT4b, N+, and/or M1 is not eligible.
• NOTE: Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (< cT1 N0) are eligible regardless of time elapsed
• Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last three months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements
• Patient must not have received prior radiation therapy to >= 25% of the bone marrow for other diseases
• Patient must not have received prior systemic anthracycline therapy
• NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
• Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible
• Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion:
• Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
• Steroids as premedications for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication)
• Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab
• Patient must not have had a major surgical procedure within 28 days prior to registration/randomization
• NOTE: Cystoscopy/ureteroscopy, stent placement or nephrostomy tube is not considered major surgery
• Patient must not have history of allogenic organ transplantation
Procedure: Biopsy, Procedure: Biospecimen Collection, Drug: Cisplatin, Procedure: Computed Tomography, Drug: Doxorubicin Hydrochloride, Biological: Durvalumab, Drug: Gemcitabine Hydrochloride, Procedure: Magnetic Resonance Imaging, Drug: Methotrexate, Biological: Pegfilgrastim, Procedure: Therapeutic Conventional Surgery, Drug: Vinblastine Sulfate
Renal Pelvis and Ureter Urothelial Carcinoma
UT Southwestern; Parkland Health & Hospital System
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A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus-associated Diseases

The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Victor Aquino
10208
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT04554914
STU-2020-0614
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Inclusion Criteria:

• Diagnosis of EBV+ disorder
• Eastern Cooperative Oncology Group performance status <= 3 for participants aged >= 16 years; Lansky score >= 20 for participants from 1 year to < 16 years
• Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator Cohort-specific
Inclusion Criteria:

• For participants with PID LPD:
• Newly diagnosed or relapsed/refractory LPD confirmed by biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or without radiographically measurable intracranial disease with EBV detected in CSF
• Participant must have systemic measurable disease and/ or CNS measurable disease
• Definitive therapy (eg, allogeneic HCT, gene therapy) for the underlying PID is planned
• Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD, as determined by the investigator
• For participants with AID LPD:
• Newly diagnosed or relapsed/refractory LPD confirmed by biopsy-proven EBV+ LPD or positive CSF cytology, with or without radiographically measurable intracranial disease, with EBV detected in CSF
• Participant must have systemic measurable disease and/ or CNS measurable disease
• Participants who are human immunodeficiency virus positive (HIV+) must meet both of the following criteria: Have an HIV viral load assessed by reverse transcription-polymerase chain reaction (RT-PCR) below the lower limit of detection and CD4 >= 50 cells/μL within 6 months prior to the first dose of tabelecleucel
• Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD, as determined by the investigator
• For participants with CNS PTLD:
• Newly diagnosed or relapsed/refractory EBV+ CNS PTLD histologically confirmed by biopsy-proven EBV+ CNS PTLD or positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF
• Participant may have systemic and CNS disease or CNS disease only
• Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD, as determined by the investigator
• For participants with EBV+ PTLD, where standard first line therapy (rituximab and/or chemotherapy) is not appropriate, including CD20-negative disease:
• Newly diagnosed, biopsy-proven EBV+ PTLD
• Ineligible for standard first-line therapy for EBV+ PTLD, as determined by the investigator
• Participants must have systemic disease measurable per Lugano Classification criteria, except when contraindicated or mandated by local practice, then MRI may be used.
• For participants with sarcoma, including LMS:
• Newly diagnosed or failed systemic first-line therapy for EBV+ sarcoma. Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ sarcoma, as determined by the investigator.
• Biopsy-proven EBV+ sarcoma
• Measurable disease using diagnostic PET/CT and/or MRI following RECIST 1.1 criteria
• For participants with CAEBV:
• Newly diagnosed or previously treated CAEBV
• Detectable EBV viremia on at least 2 occasions at a minimum of 90 days apart
• At least 3 active clinical findings (per Kimura H, et al. Front Immunol. 2017;8:1867) as: Fever >= 38.5°C; splenomegaly, lymphadenopathy, and/or hepatomegaly; cytopenia affecting at least 2 or 3 lineages in the peripheral blood (hemoglobin < 9 g/dL, platelets < 100 × 10^3/mL, neutrophils < 1 × 10^3/mL); hypogammaglobulinemia; hemophagocytosis; hepatitis; neuropathy; rash; and hydroa vacciniforme
• For participants with EBV+ viremia with HLH:
• Newly diagnosed or previously treated EBV+ viremia with HLH
• A molecular diagnosis consistent with HLH-2004 trial (per Henter JI, et al. Pediatr Blood Cancer. 2007;48:124-31) OR 5 or more of the clinical symptoms (per Jordan MB, et al. Blood. 2011;118:4041-4052): Fever >= 38.5°C; splenomegaly; cytopenia affecting at least 2 or 3 lineages in the peripheral blood (hemoglobin < 9 g/dL, platelets < 100 × 10^3/mL, neutrophils < 1 × 10^3/mL); hypertriglyceridemia (fasting >= 265 mg/dL) and/or hypofibrinogenemia (<= 150 mg/dL); hemophagocytosis in bone marrow, spleen, lymph nodes, or liver; low or absent natural killer cell (NK-cell) activity; ferritin >= 500 ng/mL; and elevated soluble CD25
Exclusion Criteria:

• Burkitt, T-cell (except in the setting of HLH), natural killer/T-cell lymphoma/LPD, Hodgkin, or transformed lymphoma
• Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment
• Suspected or confirmed Grade >= 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment
• Need for vasopressor or ventilatory support
• Prior therapy (in order of increasing washout period) prior to enrollment as:
• Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression
• Within <= 8 weeks for cellular therapies (EBV-CTLs, chimeric antigen receptor therapies directed at T cells or T-cell subsets, donor lymphocyte infusion, other CTLs); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)
• Unwilling to use protocol specified contraceptive methods
• Women who are pregnant or breastfeeding
• Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (protocol-specified dexamethasone is permitted and concludes by the time of enrollment)
• For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant
Biological: Tabelecleucel
Sarcoma, Leiomyosarcoma, Stem Cell Transplant Complications, Lymphoproliferative Disorders, Solid Organ Transplant Complications, Allogeneic Hematopoietic Cell Transplant, Brain and Nervous System, Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (CNS PTLD), EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD), EBV+ Sarcomas, Chronic Active Epstein-Barr Virus (CAEBV), Chronic Active Epstein-Barr Virus With Hemophagocytic Lymphohistiocytosis (HLH), Lymphohistiocytosis, Hemophagocytic
Allogeneic, Off-The-Shelf T-cell Immunotherapy, Epstein-Barr Virus (EBV), Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Solid Organ Transplant (SOT), Hematopoietic Cell Transplant (HCT)
Children’s Health
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Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Syed Kazmi
177531
All
18 Years to 100 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04185883
STU-2020-0332
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Inclusion Criteria:

• Men or women greater than or equal to 18 years old.
• Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Exclusion Criteria:

• Primary brain tumor.
• Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
• Myocardial infarction within 6 months of study day 1.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Drug: Sotorasib, Drug: AMG 404, Drug: trametinib, Drug: RMC-4630, Drug: afatinib, Drug: pembrolizumab, Drug: panitumumab, Drug: carboplatin, pemetrexed, docetaxel, Drug: atezolizumab, Drug: everolimus, Drug: palbociclib, Drug: MVASI® (bevacizumab-awwb), Drug: TNO155, Drug: FOLFIRI, Drug: FOLFOX, Drug: Loperamide
Advanced Solid Tumors, Colon, Lung/Thoracic, Rectum, Kirsten Rat Sarcoma (KRAS) pG12C Mutation
UT Southwestern
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Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON)

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
Call 214-648-5005
studyfinder@utsouthwestern.edu, Vukile.Mlambo@utsouthwestern.edu
Parag Joshi
164267
All
18 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04023552
STU-2021-0853
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Key Inclusion Criteria
• Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
• Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Clinically significant symptomatic peripheral artery disease Key Exclusion Criteria
• Uncontrolled hypertension
• Heart failure New York Heart Association (NYHA) class IV
• History of malignancy of any organ system
• History of hemorrhagic stroke or other major bleeding
• Platelet count ≤LLN
• Active liver disease or hepatic dysfunction
• Significant kidney disease
• Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply at the end.
Drug: TQJ230, Drug: Placebo
Cardiovascular, Cardiovascular Disease and Lipoprotein(a)
Lipoprotein(a), Lp(a),CVD, myocardial infarction, PAD,Stroke, Pelacarsen
UT Southwestern
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Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden and is projected to be the predominant subtype of HF in the near future. While multiple therapies have proven efficacious for patients with HFrEF, no pharmacological agents have demonstrably been shown to improve outcomes in HFpEF, highlighting the need for novel approaches to HFpEF treatment. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. Home-based exercise using an m-Health platform is an alternative to supervised exercise that can deliver clinician prescribed exercise interventions and wellness education though monitoring and care coordination. The goal of this study is to evaluate the feasibility and efficacy of a patient specific progressive home-based cardiac rehabilitation program leveraging the technology of the m-Health program in improving functional status, exercise capacity, and QOL in patients with HFpEF.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Vinayak.Subramanian@UTSouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05002075
STU-2021-0329
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Inclusion criteria: 1. Adults age> 18 years 2. HFpEF with left ventricular ejection fraction >50% 3. Clinically stable and no hospitalization in last 4 weeks 4. Estimated glomerular filtration rate > 45 mL/min/1.73 m2 as measured by the simplified MDRD formula 5. Stable diuretic regimen Exclusion criteria: 1. History of cancer or end stage lung disease 2. Estimated glomerular filtration rate < 45 mL/min/1.73 m2 as measured by the simplified MDRD formula 3. Recent HF decompensation 4. Inability to do exercise test 5. Inability to provide written informed consent 6. History of falls
Other: m-health cardiac rehabilitation
Heart Failure With Preserved Ejection Fraction, Cardiovascular, Heart
HFpEF, Cardiac rehabilitation
UT Southwestern
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Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Francesca.Chambers@UTSouthwestern.edu
Ron Mitchell
124198
All
10 Years to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04801771
STU-2021-0286
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Inclusion Criteria:

• Diagnosis of Down syndrome
• Age 10-21 years
• Prior adenotonsillectomy
• Severe OSA (AHI > 10, AHI < 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment
• Approval from at least two of the three physician reviewers based upon the results of a routine drug-induced sleep endoscopy (DISE) having occurred within 12 months of enrollment
• Subjects must have either tracheotomy or be ineffectively treated with CPAP due to non-compliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device
• Children and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative PSG, and questionnaire completion
• Children's parents/guardians must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation
• Children and their parents/guardians must be proficient in English
Exclusion Criteria:

• Body mass index (BMI) above the 95th percentile for subject's age
• Circumferential airway collapse at the level of the velopharynx observed during DISE
• Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration)
• Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest
• Patients with another implantable device which could interact unintentionally with the Inspire system
• Any contraindication for general anesthesia
• History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries
• Subject is currently taking muscle relaxant medication
• Life expectancy less than 12 months
• Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment
• Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling
• Subjects with a co-occurring diagnosis of autism spectrum disorder
• Subjects that have a positive β-HCG
• Subjects deemed unfit for participation by the investigator for any other reason
Device: Inspire Upper Airway Stimulation (UAS) System
Obstructive Sleep Apnea, Down Syndrome, Ear, Nose, Throat
Hypoglossal nerve stimulation
Children’s Health
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A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity. (DIRECTION)

This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Victoria.Castillo@UTSouthwestern.edu
Fatma Gul
12837
All
18 Years to 75 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04936542
STU-2021-0659
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Inclusion Criteria:

• Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent
• 2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study;
• 2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study
• Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS;
• Participants with MAS score of at least 2 at elbow, wrist and finger flexors;
• Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain);
• Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii;
• Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate;
• Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated, and for at least 1 month prior to study entry in terms of occupational and/or physiotherapy treatment, if treated, and are considered by the investigator likely to remain stable for the duration of the study;
Exclusion Criteria:

• Major limitations in the passive range of motion in the paretic upper limb;
• Major neurological impairment (other than limb paresis) that could negatively affect functional performance;
• Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm listed in Section 5.1, or requiring injection into both arms or any lower limb within the timeframe of the study;
• Hypersensitivity to any BoNT product or excipients;
• Hypersensitivity to cow's milk protein (casein);
• Infection at the proposed injection site(s);
• Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome);
• Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety;
• Women who are pregnant or lactating
• Participants treated with BoNT of any type for any indication (e.g. bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be treated during the course of the study;
• Prior history of non-responsiveness to BoNT treatment;
• Previous surgery, or administration of alcohol or phenol in the study limb 6 months or earlier from study enrolment or planned/likely to be treated during the course of the study;
• Participants treated with intrathecal baclofen, aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents), within the previous 4 weeks or planned/likely to be treated during the course of the study;
• Participants who received a COVID-19 vaccine injection within 7 days before the first planned study intervention injection, or planned/likely to be injected within 7 days after the first planned study intervention injection
• BoNT naïve participants with a history of facial neurogenic disorder (facial paralysis, polyradiculoneuropathy) (only for France).
Biological: AboBoNT-A, Biological: OnaBoNT-A
Upper Limb Spasticity
UT Southwestern
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Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas (POPLAR-NF2)

This is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Laura Klesse
13954
All
12 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05130866
STU-2021-1151
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Inclusion Criteria:
1. ≥12 years of age and weighing at least 40 kg 2. Progressive meningioma that is amenable to volumetric analysis 3. Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant) 4. Adequate bone marrow function 5. Has provided written informed consent/assent to participate in the study
Exclusion Criteria:
1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months. 2. Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening. 3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening. 4. History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence. 5. Received another investigational drug within 30 days prior to screening 6. Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of IMP.
Drug: REC-2282, Drug: Placebo
Brain and Nervous System, Neurofibromatosis Type 2
Neurofibromatosis Type 2, Neurofibromatosis Type II
UT Southwestern; Children’s Health
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A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis (OLIKOS)

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy
Call 214-648-5005
studyfinder@utsouthwestern.edu, Manuel.Huichapa@UTSouthwestern.edu
Lauren Tardo
164490
All
18 Years to 60 Years old
Phase 3
This study is also accepting healthy volunteers
NCT04486716
STU-2020-1277
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Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female participants aged 18 to 60 years (inclusive) at screening. 3. Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as defined by (Lublin et al. 2014). 4. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive). 5. Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1 course): • Participants currently treated with ocrelizumab must have received (meet all three criteria below): 1. 2 fully infused initial 300 mg ocrelizumab iv infusions 2. At least 1 fully infused 600 mg ocrelizumab iv infusions 6 months (+/- one month) 3. Last fully infused ocrelizumab dose must have occurred within 4-9 months prior to baseline •Participants currently treated with rituximab must have received (meet both criteria below): 1. At least 2 fully infused courses of rituximab 500 mg
•1000 mg iv every 6 months (+/- one month). 1. Initial loading regimens of rituximab i.e. 500 mg
•1000 mg on day 1 and on day 15, are allowed but this is consider a single course and must be followed by additional infusion(s) every 6 months (+/- one month) 2. Last fully infused rituximab dose must have occurred within 4-9 months prior to baseline. 6. Participants discontinuing aCD20 therapy for reasons including, but not limited to: physician/participant preference, access to commercial drug (e.g. insurance coverage issues) or for other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study. 7. Neurologically stable within 1 month prior to first study drug administration. 8. Must be able to use a smart device or have a caregiver that can assist.
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study: 1. Participants that have demonstrated suboptimal response to aCD20 therapy to include: a. Signs of MRI activity, defined as ≥ 2 active Gd+ T1 lesions, or any new or newly enlarging T2 lesions, documented within the past 6 months
• If a prior MRI within the last 6 months is not available, then new or newly enlarging T2 lesions should be considered "not documented" and the patient may continue screening b. Documented relapse while on stable, previous aCD20 treatment.
• Relapses during the first 3 months of intravenous aCD20 therapy are allowable if the participant is then relapse-free for the 12 months following the relapse while on intravenous aCD20 therapy c. Any signs of clinical worsening as measured by EDSS or any clinical measure documented within the last 6 months 2. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse events: 1. Severe infusion-related reactions (Grade 3 or above) 2. Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratory infections or the need for ≥ 2 courses of antibiotics since starting aCD20 therapy, if the Investigator believes this is related to therapy. 3. Decreased IgG requiring treatment with Intravenous immunoglobulin 3. Participants with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014). 4. Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015). 5. Pregnant or nursing (lactating) women 6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 6 months after stopping study medication. 7. Participants with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency). 8. Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS). 9. Participants with neurological symptoms consistent with PML or with confirmed PML. 10. Participants at risk of developing or having reactivation of syphilis or tuberculosis 11. Participants at risk of developing or having reactivation of hepatitis. 12. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration. a. There is presently no contraindication for the use of an inactivated, viral-vector-or mRNA based Sars-CoV-2 vaccine in patients who are immunocompromised. However, different Sars-CoV-2 vaccines may have various mechanisms of action and different associated potential risks. Please review local prescribing information of any specific Sars-CoV-2 vaccine and comply with local prescribing information requirements for specific contra-indications and special warnings and precautions for use.
Drug: Ofatumumab
Relapsing Multiple Sclerosis, Brain and Nervous System
Ofatumumab, Relapsing multiple sclerosis, MS, RMS, CIS, RRMS, SPM, ocrelizumab, MRI, CD19 B, adult,, OMB157, open-label, rituximab
UT Southwestern
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OA for Breast Cancer NAC Response

This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Basak Dogan
162032
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05337280
STU-2020-0598
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Inclusion Criteria:
1. 18 years and older male or female patients; 2. Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease. 3. Patient eligible to receive neoadjuvant chemotherapy
Exclusion Criteria:
1. Known Stage IV disease (breast or other cancer); 2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule); 3. Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam; 4. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline; 5. Is currently undergoing phototherapy; 6. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus); 7. Is undergoing treatment for a photosensitive disease and is experiencing photosensitivity; 8. Pregnancy; 9. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening visit that may have an impact on clinical outcomes.
Device: Imagio OA/US
Breast Cancer, Breast - Female, Breast - Male
UT Southwestern; Parkland Health & Hospital System
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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Matthew Campbell
108757
All
up to 50 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05235165
STU-2022-0187
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Inclusion Criteria:

• Patients must be < 50 years at the time of enrollment.
• Patient must have eligibility confirmed by rapid central imaging review.
• Patients must have =< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being >= 3 mm and all of which must be =< 3 cm size.
• Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
• Patients must have a histological diagnosis of osteosarcoma.
• Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
• Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
• Newly diagnosed patients must be receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
• Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least equivalent to MAP.
Exclusion Criteria:

• Patients with unresectable primary tumor.
• Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
• Patients with pleural or mediastinal based metastatic lesions, or with pleural effusion.
• Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
• Patients with evidence of extrapulmonary metastatic disease.
• Patients who received pulmonary surgery for lung metastasis prior to enrollment.
• All patients and/or their parents or legal guardians must sign a written informed consent.
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Other: Questionnaire Administration, Procedure: Thoracoscopy, Procedure: Thoracotomy
Osteosarcoma, Metastatic Osteosarcoma, Metastatic Malignant Neoplasm in the Lung, Bones and Joints, Lung/Thoracic
Children’s Health
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A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Naveneet.Kang@UTSouthwestern.edu
Oksana Hamidi
179331
All
23 Years to 81 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05171855
STU-2022-0087
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Inclusion Criteria:

• Signing of the trial specific informed consent
• Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 DXA scan
• Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above
Exclusion Criteria:

• Diabetes mellitus if any of the following are met: 1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 in trial TCH-306 2. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
• Active malignant disease or history of malignancy. Exceptions are: 1. Resection of in situ carcinoma of the cervix uteri 2. Complete eradication of squamous cell or basal cell carcinoma of the skin
• Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
• Female who is pregnant, plans to become pregnant, or is breastfeeding
• Female participant of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/section 10.4 of the protocol
• Male participant not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/ section 10.4 of the protocol
• Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures
Drug: Lonapegsomatropin
Endocrine System Diseases, Adult Growth Hormone Deficiency, Hormone Deficiency, Other Endocrine System
Human Growth Hormone, hGH, rhGH, GHD, Adult Growth Hormone Deficiency, Long Acting Growth Hormone, Lonapegsomatropin, Prodrug, Growth Hormone Replacement Therapy, Sustained Release Growth Hormone, Growth Hormone Deficiency, TransCon hGH, Skytrofa
UT Southwestern
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Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Miller
14954
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03660826
STU-2022-0415
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Inclusion Criteria:

• Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell histology is excluded
• Patients must have evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or non-measurable (detectable) disease
• Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI; patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Non-measurable (detectable) disease in a patient is defined in this protocol as one who does not have measurable disease but has at least one of the following conditions:
• Ascites and/or pleural effusion attributed to tumor;
• Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
• Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition: cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa; Note: patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
• Patients may have received non cytotoxic therapy including immunotherapy (1 prior line in either upfront or recurrent setting) but excluding cediranib, olaparib, AZD5363 (capivasertib), durvalumab (MEDI4736), or the combination of lenvatinib and pembrolizumab for the management of recurrent or persistent disease; prior hormonal therapy is allowed; hormonal therapy for grade 1 endometrial cancers with low volume or indolent disease is encouraged
• Bevacizumab, or one course of single-agent immune-checkpoint therapy, excluding durvalumab (MEDI4736), is permitted prior to enrollment on this trial
• Body weight > 30 kg
• Age >= 18
• The trial is open to females only (including women with an intact uterus with uterine cancer); fertile females of childbearing potential need to agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, and have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 (Karnofsky >= 60%) within 7 days prior to registration; patients should have no deterioration over the previous two weeks
• Hemoglobin >= 10 mg/dL with no blood transfusion in the past 28 days (within 28 days prior to administration of study drug)
• Platelet count >= 100 x 10^9/L (within 28 days prior to administration of study drug)
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 28 days prior to administration of study drug)
• Patients must have creatinine clearance estimated of >= 51 mL/min using the Cockcroft Gault equation or based on a 24-hour urine test (within 28 days prior to administration of study drug)
• Serum bilirubin =< 1.5 X upper limit of normal (ULN) (within 28 days prior to administration of study drug)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (within 28 days prior to administration of study drug)
• Urine protein: creatinine (UPC) < 1 or < 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart. Patients with 2+ proteinuria on dipstick must also have UPC < 0.5 on 2 consecutive samples (within 28 days prior to administration of study drug)
• Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib, olaparib, or AZD5363 (capivasertib)
• Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol
• Note: Patients must be willing and able to check and record daily blood pressure readings
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
• Adequately controlled thyroid function, with no symptoms of thyroid dysfunction
• Postmenopausal or evidence of non-childbearing status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to start of investigational products (IPs); postmenopausal is defined as:
• Age >= 60 years, or
• Age < 60 with any one or more of the conditions below:
• Amenorrheic for >= 1 year in the absence of chemotherapy and/or hormonal treatments,
• Luteinizing hormone and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range
• Radiation-induced oophorectomy with last menses > 1 year ago,
• Chemotherapy-induced menopause with > 1 year interval since last menses,
• Surgical sterilization (bilateral oophorectomy or hysterectomy)
• Patients must have a life expectancy of greater than 16 weeks
• Patients with a previous diagnosis of immune or inflammatory colitis or chronic diarrhea > 1 month without immune or inflammatory colitis are eligible with adequately controlled colitis (no diarrhea greater than grade 1 for at least 28 days) and in the absence of symptoms related to colonic dysfunction; patients who required steroids for prior immune related colitis are not eligible
• Females of child-bearing potential should use two forms of highly reliable methods of contraception from the time of screening until 4 weeks after discontinuing study treatment.
• Acceptable methods of contraception include:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device or intrauterine system.
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
• True abstinence (i.e., not engaging in sexual activity for the total duration of study treatment and the treatment washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control).
• Bilateral tubal occlusion or salpingectomy
• Acceptable non-hormonal birth control methods include:
• Total/True abstinence: When the patient refrains from any form of sexual intercourse and this is in line with their usual and/or preferred lifestyle; this must continue for the total duration of the trial and for at least 1 month after the last dose of study drug <>. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, or declaration of abstinence solely for the duration of a trial) and withdrawal are not acceptable methods of contraception]
• Vasectomised sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia.
• Tubal occlusion PLUS male condom
• Intrauterine device (IUD) PLUS male condom. Provided coils are copper-banded.
• Acceptable hormonal methods:
• Normal and low dose combined oral pills PLUS male condom.
• Cerazette (desogestrel) PLUS male condom. Cerazette is currently the only highly efficacious progesterone-based pill.
• Hormonal shot or injection (e.g., Depo-Provera) PLUS male condom.
• Etonogestrel implants (e.g., Implanon, Norplant) PLUS male condom.
• Norelgestromin/EE transdermal system PLUS male condom
• Intrauterine system [IUS] device (e.g., levonorgestrel releasing IUS -Mirena) PLUS male condom.
• Intravaginal device (e.g., EE and etonogestrel) PLUS male condom
Exclusion Criteria:

• Prior enrollment into a clinical trial including cediranib or olaparib; Note: prior bevacizumab is not an exclusion criterion
• Prior enrollment into a clinical trial including cediranib, olaparib, AZD5363 (capivasertib), durvalumab (MEDI4736), or the combination of lenvatinib and pembrolizumab. Note: Prior bevacizumab or single-agent immune checkpoint blockade, excluding durvalumab (MEDI4736), is not an exclusion criterion
• Prior chemotherapy, endocrine therapy, radiotherapy, or investigational agents within 4 weeks
• More than one prior line of treatment with immune checkpoint blockade therapy
• Current signs/symptoms of bowel obstruction and/or signs/symptoms of bowel obstruction within the preceding 3 months
• History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
• Uncontrolled intercurrent illness including, but not limited to known ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or psychiatric illness/social situations that would limit compliance with study requirements
• Concomitant use of known strong cytochrome (CYP) 3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting study treatments is 2 weeks for strong inhibitors, and at least 1 week for moderate inhibitors
• Concomitant use of potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start of study treatment. Concomitant use of drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment
• Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study; for women of childbearing capacity a negative pregnancy test is required
• Known human immunodeficiency virus (HIV)-positive individuals are ineligible because of the potential for pharmacokinetic interactions between many anti-HIV drugs and cediranib, olaparib, and/or AZD5363 (capivasertib); in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy
• Known active hepatitis B or hepatitis C infection on antiviral treatment
• Prior history of stroke or transient ischemic attack within the last 6 months
• Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN) per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines, for patients with the following risk factors:
• Prior treatment with anthracyclines
• Prior treatment with trastuzumab
• Prior central thoracic radiation therapy (RT), including exposure of heart to therapeutic doses of ionizing RT
• History of myocardial infarction within 6-12 months prior to start of IPs
• Prior history of other significant impaired cardiac function
• Patients with any of the following:
• History of myocardial infarction within 6 months prior to starting treatment
• Unstable angina
• Resting electrocardiogram (ECG) with clinically significant abnormal findings or with corrected QT interval (QTc) > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
• New York Heart Association functional classification of III or IV
• Prior history of hypertensive crisis or hypertensive encephalopathy
• Major surgical procedure within 4 weeks prior to starting treatment; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment
• History of intra-abdominal abscess within 3 months prior to starting treatment
• Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments
• No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
• Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
• Patients with myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML
• Central nervous system metastases:
• Symptomatic uncontrolled brain metastases requiring corticosteroid treatment; history of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting IPs; in the absence of these features and in an asymptomatic patient a scan to confirm the absence of brain metastases is not required
• Other malignancy within the last 5 years except for:
• Curatively treated basal cell or squamous cell carcinoma of skin; in situ cancer of the cervix, ductal carcinoma in situ of the breast or stage 1, grade 1 endometrial carcinoma
• Curatively treated other solid tumors including lymphomas (without bone marrow involvement) with no evidence of disease for >= 5 years prior to start of IPs
• Persisting >= grade 2 Common Terminology Criteria for Adverse Events (CTCAE) toxicity (except alopecia and grade 2 peripheral neuropathy) from previous anti-cancer treatment(s)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib, olaparib, AZD5363 (capivasertib), or durvalumab (MEDI4736)
• Pneumonitis or moderate-severe pre-existing pulmonary disease
• Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of enrollment.
• Premedication with steroids for CT scan contrast is allowed.
• Inhaled or topical corticosteroids are allowed.
• The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
• The use of physiologic doses of corticosteroids may be approved after consultation with the study chair
• Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease
• Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
• Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
• Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice)
Drug: Capivasertib, Drug: Cediranib, Drug: Cediranib Maleate, Biological: Durvalumab, Drug: Olaparib
Endometrial Undifferentiated Carcinoma, Endometrioid Adenocarcinoma, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7, Recurrent Uterine Corpus Cancer, Recurrent Endometrial Serous Adenocarcinoma
UT Southwestern
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Nasotracheal Intubation With VL vs DL in Infants Trial (NasoVISI)

Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
Call 214-648-5005
studyfinder@utsouthwestern.edu, CHRISTINA.HOWARD@UTSouthwestern.edu
Luis Zabala
125503
All
1 Day to 365 Days old
N/A
This study is NOT accepting healthy volunteers
NCT05433155
STU-2022-0661
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Inclusion Criteria:

• Males or females age 0 -365 days
• Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician
• Plan to use a neuromuscular blocking drug prior to intubation as standard of care
• Parental/guardian permission (informed consent)
Exclusion Criteria:

• Less than 36 weeks gestation
• Less than 2 kg
• History of difficult intubation
• History of abnormal airway
• Predictive of difficult intubation upon physical examination
• Preoperative endotracheal tube or tracheostomy
• Emergency cases
Device: Nasotracheal intubation
Cardiovascular, Heart, Intubation Complication, Intubation, Difficult or Failed, Hypoxia, Hypoxemia, Anesthesia Intubation Complication, Pediatric HD
Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Intubation complications, Intubation technical difficulties, Randomization, Multi-center
Children’s Health
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