Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

Completed · Phase 2

Conditions studied: Childhood Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Clear Cell Sarcoma of the Kidney, Papillary Renal Cell Carcinoma, Rhabdoid Tumor of the Kidney, Stage I Renal Cell Cancer, Stage I Renal Wilms Tumor, Stage II Renal Cell Cancer, Stage II Renal Wilms Tumor, Stage III Renal Cell Cancer, Stage III Renal Wilms Tumor, Stage IV Renal Cell Cancer, Stage IV Renal Wilms Tumor

In brief

This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Key facts

Study ID

NCT00335556

Run by

Children's Oncology Group

People needed

291

Starts

2006-06-01

Last updated by the study team

2017-07-21

Who can join

Age: any, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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