Upper Urinary Tract Cancer
EA8192
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy before Surgery for Patients with High-Grade Upper Urinary Tract Cancer
STATUS: Active
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.
- 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
- Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma
- 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
- 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
- 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 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
- 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
United States
AR
Ft. Smith
Mercy Hospital Fort Smith
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
CO
Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Poudre Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Greeley
UCHealth Greeley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Highlands Ranch
UCHealth Highlands Ranch Hospital
Status: ACTIVE
Contact: Site Public Contact
Loveland
Medical Center of the Rockies
Status: ACTIVE
Contact: Site Public Contact
DC
Washington
MedStar Washington Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Sibley Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: jquiver1@jhmi.edu
IA
Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com
Bettendorf
University of Iowa Healthcare Cancer Services Quad Cities
Status: ACTIVE
Contact: Site Public Contact
Email: kedaprile@rccqc.com
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
IL
Alton
Saint Anthony's Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Bloomington
Illinois CancerCare-Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Burr Ridge
Loyola Center for Health at Burr Ridge
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Canton
Illinois CancerCare-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Dixon
Illinois CancerCare-Dixon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Eureka
Illinois CancerCare-Eureka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Homer Glen
Loyola Medicine Homer Glen
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Maywood
Loyola University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Mount Vernon
Good Samaritan Regional Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Princeton
Illinois CancerCare-Princeton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: pallante.beth@mhsil.com
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com
Washington
Illinois CancerCare - Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
IN
Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
KS
Garden City
Central Care Cancer Center - Garden City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org
MA
Worcester
UMass Memorial Medical Center - University Campus
Status: ACTIVE
Contact: Site Public Contact
Email: cancer.research@umassmed.edu
MD
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: jhcccro@jhmi.edu
ME
Augusta
Harold Alfond Center for Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: ACTIVE
Contact: Site Public Contact
Email: LLemire@mmc.org
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: ACTIVE
Contact: Site Public Contact
Email: LLemire@mmc.org
South Portland
Maine Medical Partners - South Portland
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org
MI
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Clarkston
Newland Medical Associates-Clarkston
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org
Livonia
Hope Cancer Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Pontiac
Newland Medical Associates-Pontiac
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
MN
Burnsville
Fairview Ridges Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Minnesota Oncology - Burnsville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Cambridge
Cambridge Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Edina
Fairview Southdale Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Monticello
Monticello Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Princeton
Fairview Northland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Wyoming
Fairview Lakes Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Bolivar
Central Care Cancer Center - Bolivar
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Farmington
Parkland Health Center - Farmington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: swooden@mail.crmc.org
Joplin
Freeman Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net
Rolla
Delbert Day Cancer Institute at PCRMC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Saint Joseph
Heartland Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Mercy Hospital South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: janet.lesko@mercy.net
Missouri Baptist Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Springfield
CoxHealth South Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Mercy Hospital Springfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Sullivan
Missouri Baptist Sullivan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Washington
Mercy Hospital Washington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
NC
Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
NJ
Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
NY
Buffalo
Roswell Park Cancer Institute
Status: APPROVED
Contact: Site Public Contact
Email: askroswell@roswellpark.org
OH
Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Franklin
Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact
Oklahoma City
Mercy Hospital Oklahoma City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
PA
Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu
SC
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu
TX
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
Fort Worth
UT Southwestern / Simmons Cancer Center-Fort Worth
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
Richardson
UT Southwestern Clinical Center at Richardson / Plano
Status: ACTIVE
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu
WI
Appleton
ThedaCare Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchDept@thedacare.org
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Marinette
Aurora Bay Area Medical Group-Marinette
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Email: research.institute@phci.org
New Richmond
Cancer Center of Western Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Email: Chanda.miller@phci.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org
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.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.
