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Brief Title: MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

INTRODUCTION

  • Org Study ID: NCI-2020-09850
  • Secondary ID: NCI-2020-09850, EA8192, EA8192, U10CA180820
  • NTC ID: NCT04628767
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

DETAILED DESCRIPTION

PRIMARY OBJECTIVES:

I. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with MEDI4736 (durvalumab). (Cisplatin eligible patients [Arms A and B]) II. Evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pathologic complete response [pCR], pT0N0/ Nx). (Cisplatin ineligible patients [Arm C]).

SECONDARY OBJECTIVES:

I. To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) II. Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. (Cisplatin ineligible cohort) III. Overall survival in all, and by post chemotherapy response (ypCR, yp =< T1N0, yp >= T2Nany). (All patients) IV. To evaluate disease-free survival (DFS) in each arm separately. (All patients) V. To evaluate cancer-specific survival of patients in each arm separately. (All patients) VI. To evaluate renal function outcomes following systemic treatment and following surgery ([RNU) in each arm separately. (All patients) VII. To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with MEDI4736 (durvalumab) prior to RNU. (All patients)

OUTLINE: Patients eligible for cisplatin are randomized to Arms A or B. Patients ineligible for cisplatin are assigned to Arm C.

ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

ARM B: Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

ARM C: Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

After completion of study treatment, patients are followed up within 30 days and then every 3-6 months for up to 5 years from study entry.

  • Overall Status
    Recruiting
  • Start Date
    May 6, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)

Primary Outcome 1 - Timeframe: From randomization to the earliest of systemic recurrence, disease progression, or death from any cause, assessed up to 5 years

Primary Outcome 2 - Measure: Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)

Primary Outcome 2 - Timeframe: At surgery

CONDITION

  • Renal Pelvis and Ureter Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
STEP 1 REGISTRATION AND RANDOMIZATION

- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 60 days prior to registration with one of the following:
Upper urinary tract mass on cross-sectional imaging or
Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology
NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice

- Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration) - Platelets >= 100,000/mcL (obtained =< 14 days prior to registration) - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration) - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 14 days prior to registration)
Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration)
NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months - NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of registration
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

- Patient must have a body weight of > 30 kg

- Patient must have a life expectancy of >= 12 weeks
Patient must have a creatinine clearance > 15 ml/min as by Crockroft-Gault or 24-hour creatinine clearance within 28 days prior to registration
NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B
Patients that meet the following criteria will be assigned to the cisplatin-ineligible Arm C:
Creatinine clearance of > 15 ml/min and =< 50 ml/min - Patient must have an absolute neutrophil count (ANC) >= 1,000/mcL obtained =< 14 days prior to registration - Patient must have ECOG performance status 0-2
Patients that meet the following criteria will be randomized to cisplatin-eligible Arm A or Arm B:
Patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization - Patient must have ECOG performance status 0-1 - Patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within 28 days prior to randomization

- Patient must not have peripheral neuropathy >= grade 2 or hearing loss >= grade 3
Exclusion Criteria:
Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma

- Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

- Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
Patient must have no evidence of metastatic disease or clinically enlarged lymph nodes (>= 1.0 cm short axis) on imaging required within 28 days prior to registration (solitary slightly enlarged lymph node with negative biopsy is allowed)
NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness should also undergo baseline bone scans to evaluate for bone metastasis
Patient must not have another active (or within 2 years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =< Gleason 3+4) on surveillance or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed - Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last 3 months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements - Patient must not have received prior radiation therapy to >= 25% of the bone marrow for other diseases
Patient must not have received prior systemic anthracycline therapy
NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible

- Patient must not have an active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration or a history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome or immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diverticulosis, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible
Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of MEDI4736 (MEDI4736 (durvalumab). The following are exceptions to this criterion:
Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection

- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment

- Steroids as premedications for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication)
Patient must not have a concomitant primary urothelial carcinoma of the bladder and/or urethra
NOTE: Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed
Patient must not have prior history of muscle-invasive urothelial carcinoma with or without systemic chemotherapy (T2-4a and/or N1) within 2 years prior to registration
NOTE: Patients who have no evidence of disease (NED) for more than 2 years from the latest therapy (surgery, radiation, chemotherapy, or clinical trial) are eligible

- Patient must not have received live attenuated vaccine within 30 days prior to the first dose of MEDI4736 (durvalumab), while on protocol treatment and within 30 days after the last dose of MEDI4736 (durvalumab)

- Patient must not have had a major surgical procedure (as defined by the Investigator) within 28 days prior to registration

- Patient must not have a history of allogenic organ transplantation

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jean H Hoffman-Censits

Role: Principal Investigator

Affiliation: ECOG-ACRIN Cancer Research Group

Overall Contact

Name: Jean H Hoffman-Censits

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Sibley Memorial Hospital
Washington, District of Columbia 20016
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Facility: Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-446-5532
Research@carle.com
Facility: Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Status: Recruiting Contact: Contact
Site Public Contact
815-285-7800
Research@carle.com
Facility: Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
309-243-3605
andersonj@illinoiscancercare.com
Facility: Carle on Vermilion
Danville, Illinois 61832
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com
Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
Research@carle.com
Facility: Illinois CancerCare-Dixon
Dixon, Illinois 61021
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
andersonj@illinoiscancercare.com
Facility: Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
309-243-3605
andersonj@illinoiscancercare.com
Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Facility: Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com
Facility: Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Facility: Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
800-444-7541
ksoder@mcfarlandclinic.com
Facility: Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-446-5532
LLemire@mmc.org
Facility: Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
309-243-3605
LLemire@mmc.org
Facility: Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Status: Recruiting Contact: Contact
Site Public Contact
207-626-4855
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Status: Recruiting Contact: Contact
Site Public Contact
410-955-8804
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Carle Cancer Center
Urbana, Illinois 61801
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare - Washington
Washington, Illinois 61571
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Mary Greeley Medical Center
Ames, Iowa 50010
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
sfmc@sfmc.net
Facility: McFarland Clinic PC - Ames
Ames, Iowa 50010
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
jfields@cancersmoc.com
Facility: McFarland Clinic PC-Boone
Boone, Iowa 50036
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
jfields@cancersmoc.com
Facility: McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
jfields@cancersmoc.com
Facility: McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
hcc-clinical-trials@musc.edu
Facility: McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
734-712-3671
canceranswerline@UTSouthwestern.edu
Facility: Harold Alfond Center for Cancer Care
Augusta, Maine 04330
United States
Status: Recruiting Contact: Contact
Site Public Contact
573-334-2230
Facility: MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
314-251-7066
Facility: MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
United States
Status: Recruiting Contact: Contact
Site Public Contact
919-587-9084
Facility: Maine Medical Partners - South Portland
South Portland, Maine 04106
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
919-587-9084
Facility: Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Site Public Contact
910-587-9084
Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
843-792-9321
Facility: IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
214-648-7097
Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
214-648-7097
Facility: IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
972-669-7044
Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow

Facility: IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow

Facility: Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Rachit Kumar

Facility: Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Hope Cancer Clinic
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Principal Investigator
Rachit Kumar

Facility: Saint Mary Mercy Hospital
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Rachit Kumar

Facility: IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Principal Investigator
Elie G. Dib

Facility: Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Status: Recruiting Contact: Principal Investigator
Elie G. Dib

Facility: Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: Principal Investigator
Samer S. Kasbari

Facility: Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Status: Recruiting Contact: Principal Investigator
Vitaly Margulis

Facility: Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Medical University of South Carolina
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: N/A
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A
Facility: UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
United States
Status: Recruiting Contact: N/A
Facility: UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
Status: Recruiting Contact: N/A