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Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Randall Hughes
34544
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04997902
STU-2021-1078
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Inclusion Criteria:
1. At least 18 years of age. 2. Histologically confirmed head and neck cancer of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). 3. Documented treatment failure from at least 1 prior systemic therapy in the R/M setting, unless determined not appropriate. 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 5. Has a tumor that is dependent upon HRAS and/or PIK3CA. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Acceptable liver, renal, endocrine, and hematologic function. 8. Must be able to swallow alpelisib whole tablet or oral suspension containing crushed tablets. Feeding tube may not be used for alpelisib administration. 9. Other protocol defined inclusion criteria may apply.
Exclusion Criteria:
1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (eg, mucosal melanoma). 2. Ongoing treatment with certain anticancer agents. 3. Prior treatment (at least 1 full treatment cycle) with an FTI or PI3K, mTOR, or AKT inhibitor. 4. Received treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months. 5. Non-tolerable Grade 2, or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. 6. Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery. 7. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. 8. Participant with an established diagnosis of diabetes mellitus Type 1 or not controlled Type 2. 9. Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs based on Investigator discretion. 10. Participant has currently documented pneumonitis/interstitial lung disease. 11. Participant has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). 12. Other protocol defined exclusion criteria may apply.
Drug: Tipifarnib, Drug: Alpelisib
Lip, Oral Cavity and Pharynx, HNSCC
HRAS, PIK3CA, PI3K, Tipifarnib, Alpelisib, R/M HNSCC (Recurrent/metastatic Head and Neck Squamous Cell Carcinoma), Head and Neck Cancer, SCCHN
UT Southwestern
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Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)

The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP. The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who receive care with a combination of clinical decision support (CDS) and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care. Patients will be recruited from UT Southwestern Medical Center and Parkland Health & Hospital System.
Call 214-648-5005
studyfinder@utsouthwestern.edu, venkatraghavan.sundaram@phhs.org
Miguel Vazquez
17567
All
70 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05106036
STU-2021-0735
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Inclusion Criteria:

• High BP defined as at least 2 BP readings of SBP >= 130 or DBP >=80 during the 24 months prior to enrollment
• Clinic visit with primary care provider within the last 24 months
• Ability to write and speak English or Spanish
• 70 years of age or older 5
•Ability to understand and willingness to provide informed consent
• Owns a smartphone or tablet
Exclusion Criteria:

• Blood pressure consistently <130/80 mmHg
• Presence of dementia, Alzheimer's disease, or significant neurological disease
• Major and unstable heart disease (e.g., acute heart failure (systolic or diastolic), acute on chronic heart failure (systolic or diastolic), acute coronary syndrome or cardiac arrest, liver or renal transplantation
• Under 70 years of age
• Inability to write or speak English or Spanish
• Chronic kidney disease stage 5 or ESKD
• Chemotherapy
• Any conditions judged by the medical providers to contraindicate participation due to risk to patient safety or lack of adherence
• Expected life expectancy under a year
Other: Clinical Support Decision Tool
Hypertension, Blood Pressure, Cognitive Decline
UT Southwestern; Parkland Health & Hospital System
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A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab

This is a phase 1/2, open-label, multi-center, first-in-human, two-stage (Part 1: dose escalation and Part 2: dose expansion) study evaluating multiple doses and schedules of intravenously (IV) administered HMBD-002, with or without pembrolizumab, in patients with advanced solid tumors (i.e., locally advanced and unresectable, or metastatic).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Joshua Gruber
202745
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05082610
STU-2021-1161
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Inclusion Criteria (Phase 1 and 2 Stages) 1. Histologic or cytologic evidence of a malignant solid cancer (any histology) with advanced or metastatic disease and no available therapies known to confer clinical benefit. 2. Tumor tissue, or paraffin block, ideally from the patient's most recent biopsy. A fresh tumor biopsy will be obtained if archival samples are not available. 3. Measurable by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. 4. At least 18 years old. 5. An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. 6. Adequate hematopoietic, kidney, and liver functions. 7. A left ventricular ejection fraction (LVEF) ≥ 45%. 8. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding. A WOCBP must agree to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. 9. Male subjects must agree to follow contraceptive guidance during the study period and for at least 120 days after the last dose of study treatment. 10. Patient must give informed written consent for the study. Inclusion Criteria for HMBD-002 Phase 2 Stage Triple Negative Breast Cancer (TNBC) 1. Histologic or cytologic evidence of TNBC that is advanced or metastatic. 2. Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment. 3. Must have received appropriate treatment with at least one prior regimen for TNBC and there are no available therapies known to confer clinical benefit. Non-Small Cell Lung Cancer (Monotherapy and Combination) 1. Histologic or cytologic evidence of NSCLC that is advanced or metastatic. 2. Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment. 3. Absence of an activating mutation of the EGFR or ALK. 4. Must have received treatment with an approved therapy if there are other genomic aberrations for which targeted therapies are approved and available. 5. Must have had disease progression on at least one approved or comparable standard therapy for NSCLC. 6. Must have received appropriate prior treatment with a mAb to PD-1 or PD-L1. Multiple Other Cancers (Combination Therapy Baskets) 1. Histologic or cytologic evidence of an advanced or metastatic cancer aside from TNBC and NSCLC with no available therapies known to confer clinical benefit. 2. Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment. 3. Must have had appropriate treatment for their specific cancer and there is an absence of available therapy with a reasonable likelihood of conferring clinical benefit. Exclusion Criteria 1. If the patient received prior therapy with an anti-PD-1 or anti-PD-L1 mAb or with an agent targeting stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event. 2. Received radiotherapy within 2 weeks of treatment. 3. Received radiotherapy exceeding 30 Gray (Gy) to the lung within 6 months of the first dose of study medication. 4. Received an allogeneic tissue/solid organ transplant. 5. Received a live or live-attenuated vaccine within 30 days prior to the first dose of study medication. 6. Received a VISTA targeting agent. 7. The patient must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. 8. The patient has an active autoimmune disease that required systemic treatment in the past. 9. Presence of an uncontrolled endocrine disorder. 10. Presence of clinically significant cardiovascular disease. 11. History of (non-infectious) pneumonitis or interstitial pulmonary disease that required steroids or has current pneumonitis or interstitial pulmonary disease. 12. Presence of uncontrolled, clinically significant pulmonary disease. 13. A previous a severe hypersensitivity reaction (≥ Grade 3) to pembrolizumab and/or any of its excipients. 14. A diagnosis of immunodeficiency or is receiving chronic systemic corticosteroids at a dose that exceeds 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. 15. An uncontrolled intercurrent illness that would limit compliance with the study. 16. A positive status for human immunodeficiency virus (HIV). 17. A known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C viral (defined as HCV RNA detected) infection. 18. Oxygen-dependence. 19. A medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicity. 20. A positive COVID test within one week of study treatment if not fully vaccinated. 21. Another active malignancy that is progressing or has required active treatment within the past 3 years. 22. Known active central nervous system metastases and/or carcinomatous meningitis.
Drug: HMBD-002, Drug: Pembrolizumab
Cancer, Metastatic Cancer, Triple Negative Breast Cancer, Advanced Solid Tumor, Nonsmall Cell Lung Cancer, Malignant Neoplasm, Breast - Female, Breast - Male, Lung/Thoracic, Melanoma, skin, Other Skin, Tumor, Solid
UT Southwestern
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Study of LAU-7b for the Treatment of COVID-19 Disease in Adults (RESOLUTION)

A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.
Call 214-648-5005
studyfinder@utsouthwestern.edu, TIANNA.PETERSEN@UTSouthwestern.edu
Mamta Jain
41138
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04417257
STU-2022-0313
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Inclusion Criteria:
1. Subjects must exhibit symptoms (including at least one lower respiratory symptom such as shortness of breath or dyspnea) of COVID-19 disease at screening and/or since the start of their hospitalization (may include treated symptoms; 2. Subjects must be 18 years and older, of either gender; 3. Subjects must have at least one of the following factors/co-morbidities: 1. Controlled or uncontrolled diabetes; 2. Pre-existing cardiovascular disease, including hypertension; 3. Pre-existing respiratory disease such as COPD, asthma, emphysema; 4. Active or a former smoker with a 20 pack-years of smoking history; 5. Obesity as depicted by body mass index ≥ 30; 6. Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin >1.5 upper limit of normal, D-dimer >3.0 upper limit of normal and/or CRP >1.5 upper limit of normal 7. Patient aged 70 years and older who, based on the judgment of the Investigator, is at a higher risk of developing complications. 4. Subjects must have a documented positive test for the SARS-CoV-2 virus; 5. Subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for COVID-19 disease (care for COVID-19 disease should be for no more than 72 hours before screening, including any prior stay in another hospital); 6. Subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5 or a 6"; 7. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence is not classified as an effective method of birth control. A pregnancy test must be negative at the Screening Visit; 8. Subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; 9. Subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; 10. Subjects must be able to swallow the study drug capsules.
Exclusion Criteria:
1. Pregnancy or breastfeeding; 2. Health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. For example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. In case of doubt, the Investigator should consult with the sponsor's medical representative: 1. Presence of inherited retinitis pigmentosa; 2. Presence or history of liver failure (Child-Pugh B or C); 3. Presence or history of stage 4 severe chronic kidney disease or dialysis requirement; 4. Febrile neutropenia; 5. Presence of end-stage cancer. 3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; 4. Participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; 5. Calculated creatinine clearance (CrCL, using the Cockroft-Gault equation for example) <50 ml/min; 6. Presence of total bilirubin >1.5 x ULN (in the absence of demonstrated Gilbert's syndrome), ALT and/or AST > 2.5 x ULN; 7. Patient expected to be transferred to ICU or die in the next 24 hours.
Drug: LAU-7b, Drug: Placebo oral capsule
Other, COVID-19 Disease
Inflammation, Antiviral, Host-directed treatment, Docosahexaenoic acid, Pro-resolving
UT Southwestern
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A Study to Determine Whether Chemotherapy, Bevazicumab, and Atezolizumab is Better Than Chemotherapy Alone in Patients With Advanced Liver Cancer

This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy alone in treating patients with liver cancer that cannot be removed by surgery (unresectable) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). 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. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bevacizumab and atezolizumab with chemotherapy may kill more tumor cells in patients liver cancer than chemotherapy alone.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Hsieh
171069
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05211323
STU-2022-0391
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Inclusion Criteria:

• Patient must be >= 18 years of age
• Patient must have a histologically confirmed diagnosis of combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CC) at the local laboratory based on the 2019 World Health Organization (WHO) classification, including the classical type and intermediate cell carcinoma
• The classical type defines primary liver carcinoma with unequivocal features of both HCC and CC differentiation within the same tumors on routine histopathology with hematoxylin and eosin stains regardless of the proportion of each histology observed
• The intermediate cell carcinoma defines cancers with biphenotypic differentiation in which cells have a morphology intermediate between hepatocytes and cholangiocytes. Intermediate cell carcinoma may be associated with expression of both hepatocyte and cholangiocytic markers. Distinct HCC and CC arising in the same liver, fibrolamellar HCC, morphologically typical HCCs with only immunohistochemical expression of keratin or other cholangiocytic markers, or morphologically typical CCs with only immunohistochemical expression of hepatocytic markers will be excluded
• NOTE: Local pathology review constitutes adequate documentation of histology for initial study enrollment and treatment
• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patient must have disease which is unresectable or metastatic
• Patient must be Child Pugh class A
• Patients with prior locoregional therapy are eligible provided the following are met:
• Prior loco-regional therapy including surgical resection, chemoembolization, radiotherapy, or ablation was completed > 4 weeks prior to randomization
• Treated target lesion has increased in size by > 25% or the target lesion was not treated with loco-regional therapy
• Patients treated with palliative radiotherapy for symptoms must have completed radiotherapy > 7 days prior to randomization and the target lesion must not have been the treated lesion
• 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
• Leukocytes >= 3,000/mcL (must be obtained =< 14 days prior to protocol randomization)
• Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained =< 14 days prior to protocol randomization)
• Hemoglobin >= 9 g/dL (Patient may be transfused to meet this criterion) (must be obtained =< 14 days prior to protocol randomization)
• Platelets >= 80,000/mcL (must be obtained =< 14 days prior to protocol randomization)
• Total bilirubin =< 3 x institutional upper limit of normal (ULN) (must be obtained =< 14 days prior to protocol randomization)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 x institutional ULN (must be obtained =< 14 days prior to protocol randomization)
• Creatinine =< 1.5 x institutional ULN (must be obtained =< 14 days prior to protocol randomization)
• International normalized ratio (INR) =< 1.5 x Institutional ULN (for patients not receiving anticoagulant therapy) (must be obtained =< 14 days prior to protocol randomization). For patients receiving therapeutic anticoagulation, the patient must be on a stable anticoagulant regimen
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
• For patients with evidence of prior or active hepatitis B virus (HBV) infection (positive hepatitis B surface antigen [HBsAg] test and/or positive total hepatitis B virus core antibody [HBcAb] test at screening), the patient must be on suppressive therapy, for at least 2 weeks prior to randomization and willing to continue antiviral treatment for the length of the study
• 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 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 measurable disease. Baseline measurements and evaluations of all sites of disease must be obtained within 4 weeks prior to randomization
• Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to randomization. Patients who have undergone an EGD within 6 months of prior to randomization do not need to repeat the procedure
Exclusion Criteria:

• Patient must not have any prior history of systemic therapy for cHCC-CC
• Patient 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 randomization to rule out pregnancy
• A patient of childbearing potential is defined as anyone, 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)
• Patient must not expect to conceive or father children by abstaining from sexual intercourse or by using accepted and effective method(s) of contraception while on protocol treatment and for 6 months after the last dose of protocol treatment. Accepted and effective method(s) of contraception include those with a failure rate of < 1% per year including bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovluation, hormonal releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception
• Patient must not have new or progressive brain metastases (active brain metastases) or leptomeningeal disease
• Patients must not have laboratory evidence of active co-infection of HBV (positive HBsAg test) and hepatitis C virus (HCV) (detectable HCV ribonucleic acid [RNA]). Patients with a history of HCV infection but who are negative for HCV RNA by polymerase chain reaction (PCR) will be considered non-infected with HCV
• Patient must not have had a prior allogenic bone marrow or solid organ transplant
• Patient must not have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on baseline chest computed tomography scan
• Patient must not have active or a history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible
• Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible provided all of following conditions are met:
• Rash must cover < 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• There is no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids
• Patient must not have received prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Patient must not be on treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to randomization, or anticipate the need for systemic immunosuppressive medication during study treatment, with the following exceptions:
• Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible
• Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible
• Patient must not have inadequately controlled arterial hypertension (defined as systolic blood pressure (BP) >= 150 mmHg and/or diastolic blood pressure > 100 mmHg) prior to randomization. Patients may be on antihypersensitive medications to meet and maintain this criteria
• Patient must not have significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
• Patient may not have a history of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to randomization
• Patient must not have any evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Patient must not have uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at the time of randomization
• For patients with symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients must be recovered from the effects of radiation prior to randomization. There is no required minimum recovery period
• For patients with asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) they must be considered for loco-regional therapy if appropriate prior to randomization
• Patient must not have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed
• Patient must not have active tuberculosis
• Patient must not have undergone any major surgical procedure, other than for diagnosis, within 4 weeks prior to randomization, or have the anticipation of need for a major surgical procedure during the study
• Patient must not have any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the agents used on this study, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
• Patient must not have received any live, attenuated vaccines (e.g., FluMist [registered trademark]) within 4 weeks prior to randomization, during treatment with atezolizumab, and for 5 months after the last dose of atezolizumab
• Patient must not have received any treatment with investigational therapy within 28 days prior to randomization
• Patient must have not received treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to randomization
• Patients must not have a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• Patient must not have a known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
• Patient must not have a known allergy or hypersensitivity to any component of the atezolizumab and bevacizumab formulation
Biological: Atezolizumab, Biological: Bevacizumab, Procedure: Biospecimen Collection, Drug: Cisplatin, Procedure: Computed Tomography, Procedure: Conventional Magnetic Resonance Imaging, Drug: Gemcitabine Hydrochloride
Liver, Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Stage III Liver Cancer, Stage IV Liver Cancer
UT Southwestern
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A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)

This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Leticia.Rodriguez@UTSouthwestern.edu
Mack Mitchell
124226
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04563026
STU-2022-0491
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Inclusion Criteria:
1. Able to provide written informed consent (either from subject or subject's legally acceptable representative). 2. Onset of jaundice within prior 8 weeks. 3. Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice. 4. The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:
• Serum total bilirubin > 3.0 mg/dL
• 50 < AST < 400 IU/L
• ALT < 400 IU/L
• AST/ALT > 1.5 5. Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds. 6. Model for End-stage Liver Disease (MELD) score: 21-30. 7. Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have occurred during the current episode. 8. Male or female subjects 18 years of age or older. 9. Subjects must agree to use effective methods to prevent pregnancy while participating in the study. 10. Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
Exclusion Criteria:
1. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening. 2. Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens. 3. Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection). 4. Serum creatinine >2.5 mg/dL. 5. Subjects undergoing continuous veno-venous hemodialysis (CVVH). 6. Uncontrolled gastrointestinal bleeding. 7. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy. 8. Liver biopsy (if carried out) with findings not compatible with AH. 9. Stage ≥3 hepatic encephalopathy by West Haven criteria. 10. Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure. 11. Other concomitant cause(s) of liver disease. 12. Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas). 13. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications. 14. Existing or intended pregnancy or breast feeding. 15. Participation in another interventional clinical trial within 30 days of Screening. 16. History of organ transplantation, other than a corneal transplant. 17. Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.
Drug: DUR-928 30 mg, Drug: DUR-928 90 mg, Drug: Placebo+ Standard of Care (SOC)
Alcoholic Hepatitis, Liver
Alcoholic Hepatitis, acute alcoholic liver disease, progressive inflammatory liver injury
UT Southwestern
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PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (PROGRESS)

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Therese.Vallina@UTSouthwestern.edu
Anthony Bavry
197214
All
65 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04889872
STU-2022-0073
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Key
Inclusion Criteria:
1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key
Exclusion Criteria:
1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe placement of the introducer sheath or safe passage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF < 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Device: SAPIEN 3 / SAPIEN 3 Ultra
Aortic Valve Stenosis, Aortic Stenosis, Calcific
Transcatheter aortic valve replacement (TAVR), SAPIEN 3, SAPIEN 3 Ultra, Moderate aortic stenosis, Aortic stenosis, Transcatheter heart valve
UT Southwestern
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Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (REBIRTH)

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Carolyn.Kelly@UTSouthwestern.edu
Sonia Garg
139358
Female
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05180773
STU-2022-0383
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Inclusion Criteria:
1. Presentation with a new diagnosis of peripartum cardiomyopathy 2. Post-delivery and within the first 5 months post-partum. 3. Clinical assessment of an LVEF < or =0.35 within 2 weeks of randomization 4. Age > or = 18.
Exclusion Criteria:
1. Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum cardiomyopathy with complete recovery and a documented LVEF > 0.55 prior to or in early pregnancy) 2. Refractory hypertension (Systolic >160 or Diastolic > 95) either at the time of enrollment or at the time of the qualifying LVEF. 3. Postpartum women currently breastfeeding and planning to continue. 4. Evidence of coronary artery disease (>50% stenosis of major epicardial vessel or positive non-invasive stress test) 5. Previous cardiac transplant 6. Current durable LVAD support 7. Currently requiring support with extracorporeal membrane oxygenation (ECMO) 8. Current history of alcohol or drug abuse 9. Chemotherapy or chest radiation within 5 years of enrollment 10. Evidence of ongoing bacterial septicemia 11. Medical, social or psychiatric condition which limit the ability to comply with follow-up.
Drug: Bromocriptine, Drug: Placebo, Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT), Drug: Rivaroxaban, Drug: Second Placebo
Cardiovascular, Peripartum Cardiomyopathy, Postpartum
UT Southwestern
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A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)
Call 214-648-5005
studyfinder@utsouthwestern.edu, STEVE.HOPKINS@UTSouthwestern.edu
Jeffrey Elliott
23583
All
18 Years to 80 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT05006352
STU-2021-1039
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Key
Inclusion Criteria:

• Diagnosis of sporadic or familial ALS
• Less than 3 years since ALS symptom onset
• Stable doses of approved ALS treatments (riluzole and/or edaravone) for at least 2 months prior to screening
• Participants must be able to swallow the study intervention
• Vital capacity >50% predicted at screening
• Women must have been surgically sterilized or be postmenopausal
• Men, and sex partner if a woman of childbearing potential, must use highly effective contraception Key
Exclusion Criteria:

• Any history of unstable or poorly controlled psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
• Positive serum pregnancy test or currently lactating or breastfeeding
• History of malignancy within 5 years
• History of clinically significant neurologic disorders other than ALS
Drug: DNL343, Drug: Placebo
Amyotrophic Lateral Sclerosis, Brain and Nervous System
ALS
UT Southwestern
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4D-710 in Adult Patients With Cystic Fibrosis (CF)

This is a Phase 1/2 multicenter, open-label, single dose trial of 4D-710 investigational gene therapy in adults with CF who are ineligible for or unable to tolerate CFTR modulator therapy.
Call 214-648-5005
studyfinder@utsouthwestern.edu, LYNN.FERNANDEZ@UTSouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05248230
STU-2022-0409
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Key
Inclusion Criteria:
1. 18 years and older 2. Confirmed diagnosis of cystic fibrosis (CF) and CF lung disease including:
• Bi-allelic mutations in the CFTR gene, and
• Ineligible for CFTR modulator therapy, or previously received modulator therapy but discontinued due to adverse effects. 3. Forced expiratory volume in 1 second (FEV1) ≥50% and ≤100% of predicted (per Global Lung Function Initiative) at Screening 4. Resting oxygen saturation ≥ 92% on room air at Screening Key
Exclusion Criteria:
1. Any prior gene therapy for any indication 2. History of positive culture for Burkholderia cenocepacia, B. dolosa, or Mycobacterium abscessus within the past 24 months 3. Active allergic bronchopulmonary aspergillosis requiring management with systemic corticosteroids or antifungal therapy 4. Contraindication to systemic corticosteroid therapy 5. Requires chronic use of systemic corticosteroids or immunosuppressants to treat another condition 6. If no known diagnosis of cystic fibrosis related diabetes (CFRD), Type I, or Type II diabetes: Hemoglobin A1C ≥6.5% at Screening 7. If known diagnosis of CFRD, Type I or Type II diabetes: Hemoglobin A1C >7.5% at Screening 8. Recent history of symptomatic hyperglycemia or unstable blood glucose levels as per Investigator's assessment 9. Other conditions that, in the Investigator's opinion, may interfere with management of corticosteroid-related hyperglycemia 10. Body Mass Index (BMI) <16 11. Laboratory abnormalities at screening:
• ALT, AST or GGT ≥ 3 × the upper limit of normal (ULN)
• Total bilirubin ≥ 2 × ULN
• Hemoglobin < 10 g/dL 12. Requirement for continuous or night-time oxygen supplementation 13. Known CF liver disease with evidence of cirrhosis 14. History of thrombosis (excluding catheter-related thrombosis) or conditions associated with increased risk of thrombosis
Biological: 4D-710
Lung/Thoracic, Cystic Fibrosis Lung
CF, Cystic Fibrosis, Gene Therapy
UT Southwestern
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Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs (COVER DFUs)

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Tara.Kristof@UTSouthwestern.edu
Lawrence Lavery
116716
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05372809
STU-2022-0104
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Inclusion Criteria:

• At least 18 years of age.
• Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy.
• Presence of a DFU Wagner 2 grade wound on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study.
• If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit (SV1).
• Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 10 cm2 at the first screening visit (SV1) and first treatment visit (RV1).
• Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) of ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75 at SV1, using the affected study extremity.
• Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade level 1.
• The index ulcer has been offloaded with protocol defined offloading device throughout the study screening period for at least 14 days prior to randomization (SV1 through the first randomization visit (RV1)).
• Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile).
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Females of childbearing potential must agree to use effective methods of contraception (birth control pills, barriers, or abstinence) from screening through end of study (EOS) and undergo pregnancy tests.
• Properly obtained written informed consent.
• Subject must have stable living environment in order to manage offloading and wound care management.
• The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
Exclusion Criteria:

• Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
• Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of screening (SV1).
• Index ulcer in the opinion of the investigator is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
• Subjects with history of radiation on the same limb as the index ulcer (regardless of time since last radiation treatment).
• Subjects with exposed internal fixation on the same limb as the index ulcer (note: external fixation is allowed if deemed stable by the investigator).
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first screening visit (SV1).
• Index ulcer treated within the last 30 days prior to screening with a prohibited treatment as defined in full protocol.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids > 10mg prednisone (or equivalent) daily dose), cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface within one month prior to first screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the study.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
• In the opinion of the investigator, the subject is non-compliant with offloading or index ulcer dressing prior to randomization.
• Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization.
• Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization.
• Subject is pregnant or breast-feeding.
• Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (RV1).
• Subjects with end stage renal disease as evidenced by an eGFR <30 mL/min/1.73m2 within 120 days of randomization.
• Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from SV1 to the RV1/randomization visit.
• Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C in the opinion of the investigator at first screening visit (SV1).
• Documented history of New York Heart Association Class III or IV congestive heart failure or unstable cardiovascular disease requiring intervention within 60 days prior to screening.
• Requiring surgical intervention (excluding debridement) at the time of consenting and/or increased probability of requiring surgical intervention during study participation (note: non-invasive surgical intervention is allowed if, per the Principal Investigator, treatment will not affect subject's ability to participate in clinical trial).
• Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.
Biological: SkinTE, Other: Control
Diabetic Foot
diabetic foot ulcer, regenerative medicine, SkinTE, skin regeneration, chronic wounds, Wagner 2
UT Southwestern; Parkland Health & Hospital System
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A Study of TAK-341 in Treatment of Multiple System Atrophy

The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.
Call 214-648-5005
studyfinder@utsouthwestern.edu, STEVE.HOPKINS@UTSouthwestern.edu
Steven Vernino
67844
All
40 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05526391
STU-2022-0334
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Inclusion criteria: Diagnostic: 1. The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria. 2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator. 3. Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale. Exclusion criteria: Medical History: 1. The participant has any contraindication to study procedures. Diagnostic Assessments: 1. Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement. 2. The participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee. Other: 1. The participant has participated in another study investigating active or passive immunization against α-synuclein (αSYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
Drug: TAK-341, Drug: Placebo
Multiple System Atrophy
Drug Therapy
UT Southwestern
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Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents

Study Objective: to develop a phone-based intervention to aid parents of suicidal adolescents to adhere to lethal means safety. Lethal means counseling is the practice of educating patients and their families about limiting access to items that can be used to attempt suicide. Though lethal means counseling is standard practice in treating suicidal patients, there is little experimental literature related to its utilization across different providers and its efficacy. Further, there is a significant gap in the literature on lethal means counseling as it relates to adolescents. The proposed project will investigate a novel text message-based intervention aimed to promote lethal means safety.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Ellen.Andrews@UTSouthwestern.edu
Beth Kennard
13826
All
12 Years to 100 Years old
Phase 2
This study is also accepting healthy volunteers
NCT05423483
STU-2022-0396
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Inclusion Criteria:

• Proficiency in spoken and written English
• Own cell phone that has internet capabilities
• Adolescent participants are patient's at Children's Health SPARC IOP (ages 12-17)
• Adult participants are parents and/or legal guardians of adolescent participants (ages 18+)
Exclusion Criteria:

• Non-English speaking
Behavioral: Safe Home Text Message Reminders
Suicide
Children’s Health
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Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (PRESERVE)

Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Jeffrey Gahan
139574
Male
50 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04972097
STU-2021-1213
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Inclusion Criteria:
1. Is greater than 50 years of age 2. Has at least a 10-year life expectancy 3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c 4. Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL 5. Has Gleason score 3+4 or 4+3 6. Has no evidence of extraprostatic extension by mpMRI 7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy 8. Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation 9. Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion in the area of the MR-visible lesion 10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy) 11. Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject 12. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Exclusion Criteria:
1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium 2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis 3. Has an active urinary tract infection (UTI) 4. Has a history of bladder neck contracture 5. Is interested in future fertility 6. Has a history (within 3 years) of inflammatory bowel disease 7. Has a concurrent major debilitating illness 8. Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer 9. Has any active implanted electronic device (e.g., pacemaker) 10. Is unable to catheterize due to a urethral stricture disease 11. Has had prior or current prostate cancer therapies: 1. Biologic therapy for prostate cancer 2. Chemotherapy for prostate cancer 3. Hormonal therapy for prostate cancer within three months of procedure 4. Radiotherapy for prostate cancer 5. Surgery for prostate cancer 12. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants 13. Has had prior major rectal surgery (except hemorrhoids) 14. Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI)) 15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder 16. Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons 17. In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)
Device: Irreversible Electroporation
Prostate Cancer
Prostate Cancer, Prostate Tissue, NanoKnife System, Focal Therapy, Intermediate-Risk, Irreversible Electroporation (IRE)
UT Southwestern
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An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Farrukh Awan
180091
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05011058
STU-2022-0417
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Inclusion Criteria:

• EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
• EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
• PTLD: Must have received immunotherapy with an anti-CD20 agent.
• Hodgkin lymphoma: Must have received at least one course of anthracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
• For ENKTL and PTCL patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. ENKTL patients must have failed an asparaginase-containing regimen.
• No available therapies in the opinion of the Investigator
• Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy
• Measurable disease per Lugano 2007
• ECOG performance status 0, 1, 2
• Adequate bone marrow function Key
Exclusion Criteria:

• Presence or history of CNS involvement by lymphoma
• Systemic anticancer therapy or CAR-T within 21 days
• Antibody (anticancer) agents within 28 days
• Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant
• Less than 90 days from prior allogeneic transplant.
• Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1
• Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
• Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).
Drug: Nanatinostat in combination with valganciclovir
Lymphoid Leukemia, Epstein-Barr Virus Associated Lymphoproliferative Disorder, EBV-Related PTLD, EBV Related Non-Hodgkin's Lymphoma, Extranodal NK/T-cell Lymphoma, EBV-Positive DLBCL, Nos, EBV Associated Lymphoma, EBV-Related Hodgkin Lymphoma, EBV Related PTCL, Nos
EBV positive post-transplant lymphoproliferative disorder (PTLD), EBV lymphoma, HIV-associated lymphoma, Lymphoproliferative Disorders, Epstein-Barr Virus (EBV), EBV positive T cell lymphoma
UT Southwestern
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A Study to Measure How a New Method for Dosing Vincristine in Infants and Young Children Compares to the Standard Dosing Method in Older Children

This early phase I trial compares a new method for dosing vincristine in infants and young children to the standard dosing method based on body size in older children. Chemotherapy drugs, such as vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The same dose of a drug cannot be given to all children because they vary a lot in size from infancy to adolescence. The dose of most anticancer drugs is based on a measure of body size called the body surface area (BSA). BSA is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so adjustments have to be made to safely give anticancer drugs to the youngest patients. A new method for dosing anticancer drugs in infants and young children has been developed that uses body size to determine the dose. Collecting blood samples over time may help researchers understand how the new vincristine dosing method affects drug levels in the blood over time in infants and young children compared to older children.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Patrick Leavey
35610
All
up to 12 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT05359237
STU-2022-1175
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Inclusion Criteria:

• Patients must be =< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups:
• 0 to 6 months
• 6 months and 1 day to 12 months
• 12 months and 1 day to 36 months
• 36 months and 1 day to 12 years
• Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m^2 dose level
• Any disease status
• Patients must have a Lansky performance status of 50 or higher
• Patients must be receiving a treatment regimen that includes 1.5 mg/m^2 vinCRIStine (maximum dose 2 mg)
• Patients with a BSA < 0.6 m^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine
• Note: Patients can be studied after any dose of vinCRIStine
• Patients who are NOT enrolled on a COG clinical trial and who have a BSA < 0.6 m^2 and who are being dosed according to another infant dosing method (e.g., the 30-Rule) can receive a dose of vincristine from the infant dosing table for the pharmacokinetic study. These patients will NOT be part of the Dose Modification Assessment
• Patients with a seizure disorder may be enrolled if on allowable anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days
• Nervous system toxicities (Common Terminology Criteria for Adverse Events [CTCAE]) version (v)5 resulting from prior therapy must be grade =< 2
• Central venous access device in place (e.g., percutaneous indwelling central catheter [PICC], port, Broviac) that can be used for pharmacokinetic (PK) sampling
• VinCRIStine may be given as an outpatient, as long as all sample time points can be collected, which will require return for hour 24 sampling
Exclusion Criteria:

• Azoles antifungals and macrolide antibiotics: Patients who are currently receiving an azole or macrolide (e.g., fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, ketoconazole, eryromycin, clarithromycin, azithromycin, roxithromycin, or telithromycin) are not eligible
• CYP3A4/5 inducers/inhibitors: Patients receiving any medications or substances that are considered moderate or strong inhibitors or inducers of CYP3A4/5 are not eligible. Moderate or strong inducers or inhibitors of CYP3A4/5 should be avoided from 14 days prior to enrollment to the end of the study. Note: dexamethasone for central nervous system (CNS) tumors or metastases, on a stable dose, is allowed
• Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
• Patients with Charcot-Marie-Tooth disease
• A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
• Patients receiving a modified dose (< 1.5 mg/m^2) of vinCRIStine due to prior toxicity
• Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study
Procedure: Biospecimen Collection, Drug: Vincristine
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Children’s Health
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Abatacept in Immune Checkpoint Inhibitor Myocarditis (ATRIUM)

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Vlad Zaha
163027
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05335928
STU-2022-0624
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Inclusion Criteria:
1. Must have provided informed consent in a manner approved by the Investigator's Institutional Review Board (IRB) prior to any study-related procedure being performed. If a participant is unable to provide informed consent due to his/her medical condition, the participant's legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures; 2. Aged greater than or equal to 18 years at the time of informed consent; 3. Recent use of an FDA-approved immune checkpoint inhibitor (ICI, defined as administered an immune checkpoint inhibitor ≤ 6 months of myocarditis diagnosis), alone or in combination with other cancer therapies (i.e. chemotherapy, radiation therapy or targeted therapy). The FDA-approved ICI could be given as part of a clinical trial but not in combination with a new investigational agent which may cause myocarditis; 4. A diagnosis of myocarditis. 5. Hospitalized at the time of randomization; 6. On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug; 7. Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible; 8. The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care:
• Total white blood cell (WBC) count >2,500/μl
• Absolute neutrophil count (ANC) >1,500/μL
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <20 times the upper limit of the institutional normal ranges; 9. Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and 10. Must be willing and able to abide by all study requirements and restrictions.
Exclusion Criteria:
1. Must not have experienced any of the following (as defined in the section on the primary endpoint) in the 30-day period prior to randomization:
• A sudden cardiac arrest
• Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended).
• A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (>30 seconds, >120 beats per minute); or a ventricular tachyarrhythmia requiring intervention. 2. Recent (≤2 month) exposure to abatacept or belatacept. 3. Concurrent or recent (≤2 month) use of the following non-corticosteroid immunosuppressive therapies prior to randomization: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, and plasma exchange. The use of intravenous immunoglobulin is permitted prior to randomization and during study treatment. 4. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities. 5. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug. 6. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug. 7. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications. 8. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections; 9. Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug. 10. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study. 11. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
Drug: Abatacept plus, Drug: Placebo
Cancer, Brain and Nervous System, Eye and Orbit, Anus, Bones and Joints, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Esophagus, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Stomach, Thyroid, Urinary Bladder, Small Intestine, Soft Tissue, Unknown Sites, Myocarditis Acute
Immune checkpoint Inhibitor, Myocarditis, Abatacept, Immune therapy, Immune related adverse events
UT Southwestern
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Milrinone in Congenital Diaphragmatic Hernia

Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Michelle.Harrod@UTSouthwestern.edu
Vedanta Dariya
153943
All
up to 168 Hours old
Phase 2
This study is NOT accepting healthy volunteers
NCT02951130
STU 042017-055
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Eligibility criteria: Infants are eligible if they meet all of the following criteria:
• ≥ 36 0/7 weeks PMA by best obstetric estimate AND birth weight of ≥ 2000g
• postnatal age ≤7 days (168 hours of age)
• invasive mechanical ventilation (defined as ventilation with an endotracheal tube) and
• one arterial blood gas with an OI ≥ 10 (after tracheal tube obstruction and other easily resolvable mechanical causes for increased OI are ruled out) on the most recent arterial blood gas within 12 hours prior to the time of randomization.
• if an arterial blood gas is not available at the time of randomization, a preductal OSI of ≥ 5 can be used as an inclusion criterion instead of OI ≥ 10; (the OSI should be based on the most recent preductal pulse oximetry recording and must be within 12 hours of randomization)
• postnatal blood gas with PCO2 ≤ 80 mmHg (arterial, capillary or venous blood gas) on the most recent blood gas sample obtained within 12 hours prior to randomization Note: Criteria (iv) to (vi) must be met at the most recent analysis within 12 hours prior to randomization.
Exclusion Criteria:
Infants are ineligible if they meet any of the following criteria:
• known hypertrophic cardiomyopathy
• Note 1: infants of diabetic mothers with asymmetric septal hypertrophy can be included as long as there is no evidence of obstruction to left ventricular outflow tract on echocardiogram,
• Note 2: infants with other acyanotic congenital heart disease (CHD) and CDH may be included in the study and will be a predetermined subgroup for analysis)
• cyanotic CHD
•transposition of great arteries (TGA), total anomalous pulmonary venous return (TAPVR), partial anomalous pulmonary venous return (PAPVR), truncus arteriosus (TA), tetralogy of Fallot (TOF), single ventricle physiology
•hypoplastic left heart syndrome (HLHS), tricuspid atresia, critical pulmonic stenosis or atresia etc.,
• enrolled in conflicting clinical trials (such as a randomized controlled blinded trial of another pulmonary vasodilator therapy); Note: mothers enrolled in fetal tracheal occlusion studies such as FETO may be enrolled if permitted by investigators of the fetal tracheal occlusion study; [FETO refers to fetoscopic endoluminal tracheal occlusion and involves occlusion of fetal trachea with a balloon device at mid-gestation and subsequent removal in later gestation]
• infants with bilateral CDH o Note 3: infants with anterior and central defects are included in the study
• associated abnormalities of the trachea or esophagus (trachea-esophageal fistula, esophageal atresia, laryngeal web, tracheal agenesis)
• renal dysfunction (with serum creatinine > 2 mg/dL not due to maternal factors) or severe oligohydramnios associated with renal dysfunction at randomization; renal dysfunction may be secondary to renal anomalies or medical conditions such as acute tubular necrosis
• severe systemic hypotension (mean blood pressure < 35 mm Hg for at least 2 h with a vasoactive inotrope score of > 30)
• decision is made to provide comfort/ palliative care and not full treatment
• Intracranial bleed (including the following findings on the cranial ultrasound)
• Cerebral parenchymal hemorrhage
• Blood/echodensity in the ventricle with distension of the ventricle
• Periventricular hemorrhagic infarction
• Posterior fossa hemorrhage
• Cerebellar hemorrhage
• persistent thrombocytopenia (platelet count < 80,000/mm3) despite blood product administration on the most recent blood draw prior to randomization
• coagulopathy (PT INR > 1.7) despite blood product administration on the most recent blood draw (if checked
•there is no reason to check PT for the purpose of this study)
• aneuploidy associated with short life span (such as trisomy 13 or 18) will not be included in the study (infants with trisomy 21 can be included in the study)
• elevated arterial, venous or capillary PCO2 > 80 mmHg in spite of maximal ventilator support (including high frequency ventilation) on the most recent blood gas obtained within 12 hours prior to randomization
• use of milrinone infusion prior to randomization (the use of other inhaled pulmonary vasodilators such as iNO, inhaled epoprosternol, inhaled PGE1 and oral such as endothelin receptor antagonists is permitted
•Note: it is unlikely to be on oral pulmonary vasodilators early in the course of CDH)
• ongoing therapy with parenteral (intravenous or subcutaneous) pulmonary vasodilators such as IV/SQ prostacyclin analogs (Epoprostenol
•Flolan or Treprostinil
•Remodulin or PGE1
•Alprostadil) or IV phosphodiesterase 5 inhibitors (sildenafil
•Revatio) at the time of randomization. In addition, initiation of therapy with these two classes of parenteral medications during the first 24 hours of study drug initiation is not permitted and will be considered a protocol deviation. The risk of systemic hypotension is high during the first 24 hours of study-drug (milrinone) infusion and hence parenteral administration of other pulmonary vasodilators is avoided to minimize risk of hypotension.
• Subjects already on ECMO or patients who are being actively considered for ECMO by the neonatal or surgical team
• attending (neonatal, critical care or surgical) refusal for participation in the trial (including concern about presence of hemodynamic instability)
Drug: Milrinone, Drug: Placebo (5% Dextrose)
Congenital Diaphragmatic Hernia, Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypoplasia, Cardiovascular, Other Respiratory and Intrathoracic Organs
CDH, PPHN, HRF
Children’s Health; Parkland Health & Hospital System
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Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL

This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Tamra Slone
67555
All
1 Year to 21 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT02879643
STU 082016-009
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Inclusion Criteria Age -Patients must be ≥ 1 and ≤ 21 years of age at the time of enrollment. Diagnosis
• Cohort A: Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) or mixed phenotypic acute leukemia with ≥ 5% blasts in the bone marrow (M2 or M3), with or without extramedullary disease) or a diagnosis of lymphoblastic lymphoma.
• Cohorts B & C: Patients must have a diagnosis of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, or mixed phenotypic acute leukemia with any level of detectable disease (minimal residual disease level acceptable) with or without extramedullary disease Performance Level -Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients ≤ 16 years of age. Prior Therapy
• Patients must have recovered from the acute toxic effects (≤ Grade 2 or baseline) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, unless otherwise specified. Subjects with disease related cytopenias will be eligible.
• Patients must have relapsed or refractory disease after attaining at least a first remission. They may be in first to third relapse..
• Patients with Philadelphia chromosome t(9;22) positive disease must have received at least two prior tyrosine kinase inhibitors.
• Patients who have experienced their relapse after a Hematopoietic stem cell transplantation (HSCT) are eligible, provided they have no evidence of graft-versus-host disease (GVHD) and are at least 100 days post-transplant at the time of enrollment.
• Prior anthracycline lifetime cumulative exposure: Patients must have less than 320 mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline chemotherapy. 1. Cohort A: Patients must have less than 320 mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline chemotherapy (See Appendix 2 for anthracycline calculation worksheet). 2. Cohorts B & C: There is no limit on prior anthracycline exposure.
• Hematopoietic growth factors: It must have been at least seven days since the completion of therapy with granulocyte colony-stimulating factor (GCSF) or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).
• Biologic anti-neoplastic agents: At least seven days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond seven days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair or vice chair.
• Monoclonal antibodies: At least three half-lives (or 30 days—whichever is longer) of the antibody must have elapsed after the last dose of monoclonal antibody. (e.g., Rituximab = 66 days, Epratuzumab = 69 days)
• Immunotherapy: At least 30 days after the completion of any type of immunotherapy, e.g. tumor vaccines, chimeric antigen receptor T-cells.
• Recent prior chemotherapy: At least 10 days after standard vincristine and the completion of any type of chemotherapy induction regimen. At least 3 weeks after radiation therapy. At least 30 days after the completion of any investigational neoplastic agent is also required. An investigational agent is defined as any drug that is not approved and licensed for sale by the FDA for institutions in the United States, by Health Canada for institutions in Canada and by The Therapeutic Goods Administration for institutions in Australia. Exceptions:
• There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such; it is allowable to enroll a patient that has received IT Cytarabine (ARA-C), IT Methotrexate (MTX) or triple IT therapy within 14 days of enrollment as part of their evaluation to diagnose disease relapse. The IT therapy given within 14 days of initiation of protocol specified chemotherapy, may substitute for the day 1 IT in cohorts A and B
• Subjects with rapidly progressive disease may receive hydroxyurea until they begin study therapy;
• Patients who relapse while on maintenance-type ALL therapy or are receiving maintenance therapy for disease stabilization will not require a wash-out period before entry into this study. However, there must be at least 10 days after any dose of standard vincristine. Renal and Hepatic Function
• Renal function: Patient's serum creatinine must be ≤ 1.5 x institutional upper limit of normal (ULN) according to age. If the serum creatinine is greater than 1.5 times normal, the patient must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70milliliter/min/1.73m2. Alternatively, a 24-hour creatinine clearance may also be used.
• Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be < 5 x institutional upper limit of norm ULN. Total bilirubin must be ≤ 1.5 x ULN (except in the case of subjects with documented Gilbert's disease ≤ 5 × ULN). Cardiac Function -Patients must have a shortening fraction ≥ 27% or an ejection fraction ≥ 55% by echocardiogram, cardiac MRI or multigated acquisition scan (MUGA). Reproductive Function
• Female patients must not be pregnant and those of childbearing potential must have a negative urine or serum pregnancy test confirmed within one week prior to enrollment.
• Female patients with infants must agree not to breastfeed their infants while on this study.
• Male and female patients of childbearing potential must agree to use an effective method of contraception during the study. Exclusion Criteria Patients will be excluded if they have isolated testicular disease. Patients will be excluded if they have previously received Marqibo®. Patients will be excluded if they have a known allergy to any of the drugs used in the study, with the exception that patients with an allergy to PEG-asparaginase who can receive Erwinia asparaginase are eligible. Patients unable to receive any formulation of asparaginase may only enroll on cohort C Patients will be excluded if they have active, uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment. Patients who require azole antifungal agents will be excluded. Azoles must be discontinued at least one week prior to the start of Marqibo®. Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, another investigational agent or immunotherapy during the study period. Patients with pre-existing, persistent grade 2 or greater sensory or motor neuropathy from any cause will be excluded. Patients will be excluded if they have, significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or adherence with the protocol treatment or procedures or interfere with consent, study participation, follow up, or interpretation of study results.Patients with Down syndrome will not be eligible for enrollment on Cohort A Patients with a known history of human immunodeficiency virus (HIV) will will be excluded due to the increased risk of complications such as severe infection and unknown interaction of Marqibo® with antiretroviral drugs. Active hepatitis B or C infection as defined by seropositive for hepatitis B (hepatitis B surface antigen (HBsAg)) or hepatitis C and elevated liver transaminases (defined as above the ULN per the institution normal ranges).
Drug: Marqibo
ALL, Childhood, Lymphoblastic Leukemia, Acute, Childhood, Lymphoblastic Leukemia, Acute, Lymphoid Leukemia
Children’s Health
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Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02201992
STU 082014-087
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Inclusion Criteria:

• Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
• Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
• Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5? and 3? ALK probes or the loss of the 5? probe; this must have been performed:
• By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
• Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
• Women must not be pregnant or breast-feeding
• All females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• No known interstitial fibrosis or interstitial lung disease
• No prior treatment with crizotinib or another ALK inhibitor
• No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
• No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
• Patients must be adequately recovered from surgery at the time of randomization
• The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
• The maximum time requirement between surgery and randomization must be:
• 3 months (90 days) if no adjuvant chemotherapy was administered
• 8 months (240 days) if adjuvant chemotherapy was administered
• 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
• Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization
• NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
• NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Total serum bilirubin =< 1.5 x ULN
• Absolute neutrophil count (ANC) >= 1500/mm^3
• Platelets >= 30,000/mm^3
• Hemoglobin >= 8.0 g/dL
• Serum creatinine =< 2 x ULN
• Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined
• Patients must not have any history of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer; patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 years
• Patients may not be receiving any other investigational agents while on study
Other: Clinical Observation, Drug: Crizotinib, Other: Laboratory Biomarker Analysis
Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, ALK Gene Rearrangement, ALK Gene Translocation, ALK Positive, Lung/Thoracic
UT Southwestern; Parkland Health & Hospital System
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Feasibility Study Using Imaging Biomarkers in Lung Cancer

The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3 centimeters). A pulmonary nodule is a mass or growth on the lung. An MRI is a scanning device that uses magnets to make images (pictures) of the body. This study is being done to determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying a small sample of the tumor once it is removed at the time of surgery.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Kemp Kernstine
125019
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02095808
STU 052012-065
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Inclusion Criteria:

• Subjects of all races and ethnic origins over 18 years of age will be recruited.
• Patients must have suspicious or known to be malignant solitary pulmonary nodule,5cm or less in size.
Exclusion Criteria:

• Patients with a contraindication to MRI examinations will be excluded from this study. Contraindications to MRI examinations include:
• Medically unstable
• Heart failure
• Unstable angina
• Child bearing
• Lactating
• Not a surgical candidate
• Any contraindication per MRI Screening Form (Appendix A attached). This is the same form used in clinical practice at UT Southwestern.
• Titanium implants, pacemakers
• Poorly controlled diabetes
• Body weight greater than 300 pounds
• Claustrophobic
• Since each patient is receiving a gadolinium based contrast agent intravenously:
• eGFR < 45 mL/min/1.73m2
• Sickle cell disease
• Hemolytic anemia
Procedure: Imaging Biomarkers
Lung Cancer, Lung/Thoracic
UT Southwestern
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Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Yair Lotan
59883
Male
30 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02064673
STU 042013-080
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Inclusion Criteria:

• Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
• pathologically confirmed T1-T3 disease
• no sign of lymph node or metastatic disease
• pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20.
• Eastern Cooperative Oncology Group(ECOG) status 0-2
• adequate renal and liver function as well as bone marrow reserve (measured serum creatinine <2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL)
• 30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
• focally positive surgical margins are permitted
• no plan to receive adjuvant hormone or radiation therapy
• PSA at the time of enrollment must be undetectable
• life expectancy of 3 years
Exclusion Criteria:

• must not have exceeded 3 months from time of surgery to enrollment into study
• T3b or T4 or node positive disease
• macroscopic residual disease after surgery
• hormone therapy before surgery
• history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
• radiation therapy as primary treatment after surgery
• INR value greater than 1.5
• AST/ALT are equal or greater than 2 times the upper limit of normal
• antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
• history of gastric or duodenal ulcers or untreated hyperacidity syndromes
• patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
Drug: Curcumin, Drug: placebo
Prostate Cancer, Prostate
prostate cancer, radical prostatectomy
UT Southwestern; Parkland Health & Hospital System
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JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer (STABLE-MATES)

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Robert Timmerman
69821
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02468024
STU 022015-069
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Inclusion Criteria:

• Age > 18 years.
• ECOG performance status (PS) 0, 1, or 2.
• Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. Those with ground glass opacities and <50% solid component will be excluded.
• The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization.
• Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT scan of the chest and upper abdomen performed within 180 days prior to randomization. Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms.
• All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy within 180 days of randomization.
• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection.
• Tumor located peripherally within the lung. NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See below. Patients with non-peripheral (central) tumors are NOT eligible.
• No evidence of distant metastases.
• Availability of pulmonary function tests (PFTs
•spirometry, DLCO, +/- arterial blood gases) within 180 days prior to registration. Patients with tracheotomy, etc, who are physically unable to perform PFTs (and therefore cannot be tested for the Major criteria in 3.1.11 below) are potentially still eligible if a study credentialed thoracic surgeon documents that the patient's health characteristics would otherwise have been acceptable for eligibility as a high risk but nonetheless operable patient (in particular be eligible for sublobar resection).
• Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria
• Major Criteria
• FEV1 ≤ 50% predicted (pre-bronchodilator value)
• DLCO ≤ 50% predicted (pre-bronchodilator value)
• Minor Criteria
• Age ≥75
• FEV1 51-60% predicted (pre-bronchodilator value)
• DLCO 51-60% predicted (pre-bronchodilator value)
• Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) as estimated by echocardiography or right heart catheterization
• Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons. The belief must be declared and documented in the medical record prior to randomization.
• Poor left ventricular function (defined as an ejection fraction of 40% or less)
• Resting or Exercise Arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%
• pCO2 > 45 mm Hg
• Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3.
• No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor (e.g. previous lung cancer) on the ipsilateral side. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted.
• No prior lung resection on the ipsilateral side.
• Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Peri-menopausal women must be amenorrheic > 12 months prior to registration to be considered not of childbearing potential.
• No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
• Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:

• evidence of distant metastases
• prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. No prior lung resection on the ipsilateral side.
• pregnant and lactating women
• prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
Procedure: Lung Surgery, Radiation: Radiation therapy
Non-Small Cell Lung Cancer, Lung/Thoracic
UT Southwestern; Parkland Health & Hospital System
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Phase 1/2a Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002) (AL3818)

This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding oral AL3818 to standard platinum-based chemotherapy concurrently and continued as a maintenance therapy for up to 12 months.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Miller
14954
Female
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02584478
STU 042017-051
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Inclusion Criteria:

• Female ≥ 18 years
• Previously histologically proven diagnosis of a. Endometrial Cancer: recurrent or persistent endometrial carcinoma refractory to conventional therapy or established treatments with the following histologic epithelial cell types i. Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma b. Ovarian Cancer: recurrent or persistent ovarian or primary peritoneal cancer refractory to established treatments with the following histologic epithelial cell types i. Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified. c. Cervical cancer: squamous cell carcinoma of the cervix refractory to conventional therapy or established treatments with the following histologic epithelial cell types: i. Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI or ≥ 10mm when measured by spiral CT.
• Life expectancy ≥ 3 months
• Able to take orally administered study medication
• Must sign approved informed consent and authorization permitting release of personal health information.
• Patient must have adequate: 1. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm^3, equivalent to Common Toxicity Criteria (CTC) grade 1, platelets ≥ 100,000/mm^3 2. Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN), CTC grade 1. Note: If creatinine is > 1.5 x ULN, creatinine clearance must be > 50 mL/min. 3. Hepatic function: bilirubin ≤ 1.5 x ULN (CTC grade 1) or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; AST and ALT ≤ 3.0 ×ULN. 4. Coagulation profile: PT such that international normalized ratio (INR) is ≤ 1.55 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a PTT < 1.2 times control. 5. ECOG performance ≤ 2
• Patient of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of AL3818 until 4 weeks after discontinuing study drug and have a negative serum pregnancy test prior to study entry and cannot be lactating.
• Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.
Exclusion Criteria:

• Patients with serious, non-healing wound, ulcer or bone fracture.
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
• Patient with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or history of cerebrovascular accident (CVA, stroke) transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study. a. Patients with metastatic CNS tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (including radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy.
• Patients with proteinuria: patients discovered to have a urine protein of 1+ on dipstick or ≥ 30 mg/dl at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1000 mg protein/24 hours to allow participation in the study.
• Patients with clinically significant cardiovascular disease including uncontrolled hypertension, myocardial infarction or unstable angina within 6 months prior to registration. New York Heart Association (NYHA) Grade II or greater congestive heart failure, Serious cardiac arrhythmia requiring medication, Grade II or greater peripheral vascular disease.
• Patients who are pregnant or nursing.
• Women of childbearing potential who are unable to use contraceptive measures during study therapy and for at least 3 months after completion of AL3818 therapy.
• Patients with uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
• Hemoptysis within 3 months prior to first scheduled dose of AL3818.
• Patients with acute or chronic liver disease, active hepatitis A or B with known cirrhosis or liver dysfunction.
• Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of AL3818 or a major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to first scheduled dose of AL3818.
• Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 who cannot be switched to other alternative medications .
• Known history of human immunodeficiency virus infection (HIV).
• Subjects with active bacterial infections (other than uncomplicated urinary tract infection) and/or receiving systemic antibiotics.
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
• History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months that in the opinion of the investigator may place the patient at risk of side effects on an anti-angiogenesis product.
• History of significant vascular disease (e.g. aortic aneurysm, aortic dissection).
• Intra-abdominal abscess within the last 3 months.
• Pre-existing uncontrolled hypertension as documented by 2 baseline BP readings taken at least one hour apart, defined as systolic bloodpressure (BP) >160 mm Hg or diastolic BP > 90 mm Hg pressure.
• QTcF>470 msec on screening ECG.
• A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• The use of concomitant medications that prolong the QT/QTc interval. Baseline echocardiogram (within 2 months) with left ventricular ejection fraction (LVEF) < 50%.
• History of difficulty swallowing, malabsorption, active partial or complete bowel obstruction, or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of AL3818.
• History of pancreatitis and/or renal disease or pancreatitis that includes histologically confirmed glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies.
• Treatment with an investigational agent within the longest time frame of either 5 half- lives or 30 days of initiating study drug.
• Known recreational substance abuse.
• Known hypersensitivity to AL3818 or components of the formulation.
Drug: AL3818, Drug: Carboplatin, Drug: Paclitaxel
Primary Peritoneal Carcinoma, Endometrial Carcinoma, Cervical Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Cervix, Corpus Uteri, Ovary
Dual receptor Tyrosine Kinase Inhibitor, Anti-angiogenic therapy, Combination Therapy
UT Southwestern; Parkland Health & Hospital System
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Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET)

This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Ann Leitch
14231
Female
40 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02926911
STU 052017-034
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Inclusion Criteria:

• Diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS without invasive breast cancer (date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS) OR: atypia verging on DCIS OR: DCIS + LCIS (mix and/or separate locations in the same breast)
• A patient who has had a lumpectomy or partial mastectomy with margins positive for DCIS (i.e. <2mm/ink on tumor) as part of their treatment for a current DCIS diagnosis is also eligible (post-excision bilateral mammogram required at enrollment to establish a new baseline)
• No previous DCIS or invasive breast cancer in ipsilateral breast 5 years prior to current DCIS diagnosis
• 40 years of age or older at time of DCIS diagnosis
• ECOG performance status 0 or 1
• No contraindication for surgery
• Baseline imaging (must include dimensions):
• Unilateral DCIS: contralateral normal mammogram ≤ 6 months of registration and ipsilateral breast imaging ≤ 120 days of registration (must include ipsilateral mammogram; can also include ultrasound or breast MRI)
• Bilateral DCIS: bilateral breast imaging ≤ 120 days of registration (must include bilateral mammogram; can also include ultrasound or breast MRI)
• DCIS s/p lumpectomy: post excision mammogram on side of excision ≤ 60 days of registration
• Pathologic criteria:
• Any grade I DCIS (irrespective of necrosis/comedonecrosis)
• Any grade II DCIS (irrespective of necrosis/comedonecrosis)
• Absence of invasion or microinvasion
• Diagnosis of DCIS confirmed on core needle biopsy, vacuum-assisted or surgery ≤ 120 days of registration
• ER(+) and/or PR(+) by IHC (≥ 10% staining or Allred score ≥ 4) unless atypia verging on DCIS in which case biomarker criterion does not apply
• HER2 0, 1+, or 2+ by IHC if HER2 testing is performed
• Histology slides reviewed and agreement between two clinical pathologists (not required to be at same institution) that pathology fulfills COMET eligibility criteria. In cases of disagreement between the two pathology reviews about whether or not a case fulfills the eligibility criteria, a third pathology review will be required.
• At least two sites of biopsy for those cases where individual mammographic extent of calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling pathology eligibility criteria (ER/PR testing required for second biopsy)
• Amenable to follow up examinations
• Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document
• Reads and speaks Spanish or English
Exclusion Criteria:

• Male DCIS
• Grade III DCIS
• Concurrent diagnosis of invasive or microinvasive breast cancer in either breast
• Documented mass on examination or mass/hypoechoic area on imaging at site of DCIS prior to biopsy yielding diagnosis of DCIS, with exception of: subsequent lumpectomy or partial mastectomy (with positive DCIS margins i.e. <2mm/ink on tumor) followed by a post-surgery MMG; fibroadenoma at a distinct/separate site from site of DCIS; or diagnosis of mass/hypoechoic area as a cyst or a papilloma. In cases of uncertainty about whether the mass was present on physical examination prior to biopsy, the following criteria should be applied: if mammogram noting abnormal findings is diagnostic MMG = symptomatic/if mammogram noting abnormal findings is screening MMG = asymptomatic. If a patient has a mass on imaging that is biopsied (worked-up) and does not show invasive breast cancer, they are eligible. If a patient has a mass on initial MMG that is not seen on subsequent MMG, they are eligible (if initial mass occurred due to additional work-up).
• Any color/bloody nipple discharge (ipsilateral breast)
• Mammographic finding of BIRADS 4 or greater within 6 months prior to registration at site of breast other than that of known DCIS, without pathologic assessment
• Use of investigational cancer agents within 6 weeks prior to diagnosis of DCIS
• Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
• Pregnancy. If a woman has been confirmed as pregnant, she will not be eligible to take part in the trial. If she suspects there is a chance that she may be pregnant, a pregnancy test should be undertaken, although a pregnancy test for all women of child-bearing potential is not mandatory. In addition, if a woman becomes pregnant once registered to the trial, she can continue to be followed (endocrine therapy is not a mandatory requirement of the study)
• Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene use in the 6 months prior to registration
• Current use of exogenous hormones (i.e. oral progesterone)
Other: Surgery, Other: Active Monitoring
DCIS, Ductal Carcinoma in Situ, Breast - Female, Breast - Male
Ductal Carcinoma
UT Southwestern; Parkland Health & Hospital System
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PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
Call 214-648-5005
studyfinder@utsouthwestern.edu, stephanie.timsah@childrens.com
Aakash Goyal
117056
All
1 Year to 16 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT02401035
STU 032017-112
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Inclusion Criteria:

• Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
• Body weight > 5th percentile for age.
• Y-site or dedicated IV line for administration of pantoprazole sodium.
• Expected survival for at least 30 days.
• Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.
Exclusion Criteria:

• Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
• 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 subject inappropriate for entry into this study.
• Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
• Serum CK levels >3x ULN.
• Known history of HIV or clinical manifestations of AIDS.
• Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.
• History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.
• Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.
• Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
• Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.
• Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).
• ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.
• In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.
• History of sensitivity to heparin or heparin induced thrombocytopenia.
Drug: IV pantoprazole
Gastroesophageal Reflux Disease
candidate for acid suppression therapy, presumptive diagnosis of GERD, clinical diagnosis of suspected GERD, symptomatic GERD, endoscopically proven GERD
Children’s Health
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Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Naomi Winick
18066
All
8 Years to 16 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03223753
STU 112017-022
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Inclusion Criteria:

• All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission
• Patient must have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the past 12 months at a Childrens Oncology Group (COG) institution
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age
• At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week
• Patient and at least one parent/guardian are able to read and write English, Spanish, and/or French; at least 1 parent/guardian must be able to read and write English, Spanish, and/or French in order to assist the patient with using their physical activity tracking device account
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with previous hematopoietic stem cell transplant (HSCT)
• Patients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
• Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test
• Female patient who is postmenarcheal and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation
• Patients with a cognitive, motor, visual or auditory impairment that prevents computer use (e.g. unresolved posterior fossa syndrome) are not eligible
Other: Educational Intervention, Other: Internet-Based Intervention, Other: Internet-Based Intervention, Other: Laboratory Biomarker Analysis, Device: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Carcinoma In Situ, Malignant Solid Neoplasm, Lymphoid Leukemia, Hematopoietic and Lymphoid System Neoplasm
Children’s Health
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Neurocognitive Decline in Patients With Brain Metastases

The phase I component of the study is to identify maximal tolerated dose (MTD). The phase II is to evaluate neurocognitive decline.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Zabihullah Wardak
147951
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03508752
STU 122016-064
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Inclusion Criteria:
1. Age ≥ 18 years. 2. ECOG Performance Score of 2 or better/Karnofsky Performance score of 50-60 or better. 3. Biopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study. 4. Six or more metastases on diagnostic or treatment planning imaging, which include either CT Brain (with contrast) or MR Brain (with or without contrast) imaging. 5. Largest tumor <= 4 cm. 6. No prior SRS to the lesions which will be treated on protocol. 7. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 8. Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
1. Prior whole brain radiotherapy 2. Patients with leptomeningeal metastasis. (NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.) 3. Patients with life expectancy < 4 months. 4. Psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. 5. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Radiation: Stereotactic Radiosurgery
Brain Metastases, Brain and Nervous System
UT Southwestern; Parkland Health & Hospital System
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Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Hemangi.Dhole@UTSouthwestern.edu
Nitin Jain
186541
All
50 Years to 84 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03295994
STU 012018-095
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Inclusion Criteria:

• Aged =>50 years to <85 years
• Shoulder pain and/or loss of range of active motion, strength or function
• MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
• Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
• Ability and willingness to provide informed consent
Exclusion Criteria:

• Primary diagnosis is something other than a rotator cuff tear
• History (in last 2 years) of shoulder fracture involving the humeral head on affected side
• Previous rotator cuff surgery on affected side
• Isolated subscapularis &/or teres minor tear on affected side
• Acute rotator cuff tear caused by a severe trauma
• Shoulder used as a weight-bearing joint
• Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
• Glenohumeral osteoarthritis on xrays/MRI
• Grade 4 fatty infiltration of rotator cuff (any tendons)
• Candidate for shoulder arthroplasty at baseline
• Non-English speaking
Procedure: Operative, Procedure: Non-Operative
Rotator Cuff Tear
arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear
UT Southwestern; Parkland Health & Hospital System
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE)

The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Maria.Martinez2@childrens.com
Ryan Butts
169606
All
up to 21 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03386539
STU 122017-025
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Inclusion Criteria:
1. Orthotopic heart transplantation 2. Age < 21 years at time of transplant 3. Stable immunosuppression at the time of randomization with no contraindication to everolimus, tacrolimus, or mycophenolate mofetil 4. Planned follow-up at a study site for the 30 month duration of the study. 5. Subject or legal adult representative capable of providing informed consent (in general, assent will be sought for children aged 12 years or older).
Exclusion Criteria:
1. Multi-organ transplant (e.g. heart-lung or heart-liver). 2. Known hypersensitivity to everolimus, sirolimus, tacrolimus or mycophenolate mofetil (MMF), or to components of the drug products. 3. Patients on maintenance corticosteroid therapy exceeding a dose equivalent of prednisone 0.1 mg/kg/day at randomization. 4. High-risk for rejection defined as active rejection, recurrent (≥ 2 episodes of grade 2R rejection) cellular rejection, recurrent rejection (≥ 2 episodes of any grade) with hemodynamic compromise, steroid-resistant rejection or unresolved antibody-mediated rejection during the first 6 months post-heart transplant 5. Graft dysfunction (LVEF <40% or wedge pressure >22 mmHg or cardiac index <2.2 L/min/m2) 6. Stage 4 or 5 CKD (eGFR <30 ml/min/1.73 m2) or moderate proteinuria (urine protein to urine creatinine ratio >0.5 mg/mg). 7. Active infection requiring hospitalization or treatment dose medical therapy. 8. Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the Site Principal Investigator. 9. Fasting Serum Cholesterol ≥300 mg/dL OR greater than or equal to 7.75 mmol/L, AND fasting triglycerides ≥2.5x the upper limit of normal (ULN). Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication, and reduction of serum cholesterol and triglyceride levels to below exclusion ranges is confirmed. 10. Uncontrolled diabetes mellitus. 11. Diagnosis of post-transplant lymphoproliferative disorder (PTLD) during the first 6 months post-heart transplant. 12. History of non-adherence to medical regimens. 13. Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and cannot discontinue the treatment 14. Patients who are pregnant or breast-feeding or intend to get pregnant during the study period.
Drug: Everolimus, Drug: Tacrolimus, Drug: Mycophenolate Mofetil
Post-transplant Lymphoproliferative Disorder, Chronic Kidney Diseases, Pediatric Heart Transplantation, Immunosuppression, Cardiac Allograft Vasculopathy, Heart Transplant Failure and Rejection, Heart Transplant Infection
heart transplantation, children, everolimus, tacrolimus, mycophenolate mofetil, randomized clinical trial
Children’s Health
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