Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Childhood Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Clear Cell Sarcoma of the Kidney
About this trial
This is an interventional treatment trial for Childhood Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Newly diagnosed disease of 1 of the following histologic types: Focal anaplastic Wilms' tumor Diffuse anaplastic Wilms' tumor Clear cell sarcoma of the kidney Malignant rhabdoid tumor (renal or extrarenal) Renal cell carcinoma Clear cell Papillary Renal medullary Oncocytoid Sarcomatoid Chromophobe Translocation Collecting duct Carcinoma associated with neuroblastoma Renal cell carcinoma unclassified Specimens/materials must be submitted for central review by Day 7 Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated Karnofsky performance status (PS) must be >= 50 for patients > 16 years if age and Lansky PS must be >= 50 for patients =< 16 years of age Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study Total bilirubin =< 1.5 times upper limit of normal (ULN) for age Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ ALT]) < 2.5 times ULN for age Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram Female patients of childbearing age must have a negative pregnancy test Female patients who are lactating must agree to stop breast-feeding Sexually active patients of childbearing potential must agree to use effective contraception 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
Sites / Locations
- Children's Hospital of Alabama
- University of Alabama at Birmingham
- University of South Alabama
- Phoenix Childrens Hospital
- University of Arizona Health Sciences Center
- Arkansas Children's Hospital
- Southern California Permanente Medical Group
- Loma Linda University Medical Center
- Miller Children's Hospital
- Children's Hospital Los Angeles
- Children's Hospital Central California
- Children's Hospital and Research Center at Oakland
- Kaiser Permanente-Oakland
- Childrens Hospital of Orange County
- Lucile Packard Children's Hospital Stanford University
- Rady Children's Hospital - San Diego
- University of California San Francisco Medical Center-Parnassus
- Children's Hospital Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- Connecticut Children's Medical Center
- Alfred I duPont Hospital for Children
- Children's National Medical Center
- Lombardi Comprehensive Cancer Center at Georgetown University
- Broward Health Medical Center
- Golisano Children's Hospital of Southwest Florida
- Memorial Healthcare System - Joe DiMaggio Children's Hospital
- Nemours Children's Clinic-Jacksonville South
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Children's Hospital
- Baptist Hospital of Miami
- Florida Hospital Orlando
- UF Cancer Center at Orlando Health
- Nemours Children's Clinic - Pensacola
- All Children's Hospital
- Saint Joseph Children's Hospital of Tampa
- Saint Mary's Hospital
- Children's Healthcare of Atlanta - Egleston
- Memorial University Medical Center
- University of Hawaii Cancer Center
- Tripler Army Medical Center
- Saint Luke's Mountain States Tumor Institute
- Lurie Children's Hospital-Chicago
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Loyola University Medical Center
- Advocate Children's Hospital-Oak Lawn
- Advocate Lutheran General Hospital.
- Saint Jude Midwest Affiliate
- Southern Illinois University
- Riley Hospital for Children
- Saint Vincent Hospital and Health Services
- Blank Children's Hospital
- University of Iowa Hospitals and Clinics
- University of Kentucky/Markey Cancer Center
- Kosair Children's Hospital
- Tulane University Health Sciences Center
- Children's Hospital New Orleans
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
- Walter Reed National Military Medical Center
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- University of Massachusetts Medical School
- C S Mott Children's Hospital
- Wayne State University/Karmanos Cancer Institute
- Saint John Hospital and Medical Center
- Michigan State University Clinical Center
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Bronson Methodist Hospital
- Kalamazoo Center for Medical Studies
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- Mayo Clinic
- University of Mississippi Medical Center
- The Childrens Mercy Hospital
- Cardinal Glennon Children's Medical Center
- Washington University School of Medicine
- Saint John's Mercy Medical Center
- Children's Hospital and Medical Center of Omaha
- University of Nebraska Medical Center
- Nevada Cancer Research Foundation CCOP
- Dartmouth Hitchcock Medical Center
- Hackensack University Medical Center
- Morristown Memorial Hospital
- UMDNJ - Robert Wood Johnson University Hospital
- Newark Beth Israel Medical Center
- Saint Joseph's Regional Medical Center
- Overlook Hospital
- University of New Mexico Cancer Center
- University of New Mexico
- Roswell Park Cancer Institute
- The Steven and Alexandra Cohen Children's Medical Center of New York
- New York University Langone Medical Center
- Columbia University Medical Center
- Memorial Sloan-Kettering Cancer Center
- Weill Medical College of Cornell University
- University of Rochester
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Mission Hospital-Memorial Campus
- University of North Carolina
- Carolinas Medical Center
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- East Carolina University
- Wake Forest University Health Sciences
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Childrens Hospital
- Cleveland Clinic Foundation
- Nationwide Children's Hospital
- Dayton Children's Hospital
- The Toledo Hospital/Toledo Children's Hospital
- Mercy Children's Hospital
- University of Oklahoma Health Sciences Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Legacy Emanuel Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Penn State Hershey Children's Hospital
- Children's Hospital of Philadelphia
- Saint Christopher's Hospital for Children
- Children's Hospital of Pittsburgh of UPMC
- Rhode Island Hospital
- Palmetto Health Richland
- BI-LO Charities Children's Cancer Center
- Greenville Cancer Treatment Center
- Sanford USD Medical Center - Sioux Falls
- T C Thompson Children's Hospital
- East Tennessee Childrens Hospital
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Science Center-Amarillo
- Dell Children's Medical Center of Central Texas
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- University of Texas Southwestern Medical Center
- Cook Children's Medical Center
- Baylor College of Medicine
- Covenant Children's Hospital
- Methodist Children's Hospital of South Texas
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Primary Children's Hospital
- University of Vermont College of Medicine
- Inova Fairfax Hospital
- Childrens Hospital-King's Daughters
- Naval Medical Center - Portsmouth
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Children's Hospital
- Seattle Children's Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- Mary Bridge Children's Hospital and Health Center
- Madigan Army Medical Center
- West Virginia University Charleston
- University of Wisconsin Hospital and Clinics
- Marshfield Clinic
- Midwest Children's Cancer Center
- John Hunter Children's Hospital
- Sydney Children's Hospital
- The Children's Hospital at Westmead
- Royal Brisbane and Women's Hospital
- Royal Children's Hospital-Brisbane
- Women's and Children's Hospital-Adelaide
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- University of Alberta Hospital
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Child Health Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Chedoke-McMaster Hospitals
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- The Montreal Children's Hospital of the MUHC
- Centre Hospitalier Universitaire Sainte-Justine
- Centre Hospitalier Universitaire de Quebec
- Saskatoon Cancer Centre
- Starship Children's Hospital
- San Jorge Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Surgery
Treatment (UH-1)
Treatment (window/UH-1)
Treatment (UH-2)
Treatment (regimen I)
Treatment (regimen DD-4A)
Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.
Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.
Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.