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Therapeutic Areas: Oncology | Nephrology/Urology
Disease Category: Kidney Cancer

Trial Information

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor COG-AREN0533

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

PURPOSE: This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor.

InclusionCriteria:

DISEASE CHARACTERISTICS:

• Newly diagnosed Wilms' tumor meeting 1 of the following criteria:
  • Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
• Has undergone nephrectomy within the past 2 weeks
• Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
• Enrolled in this study before beginning week 7 chemotherapy
• Previously enrolled in clinical trial COG-AREN03B2

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST or ALT < 2.5 times ULN
• Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

ExclusionCriteria:

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532
• No concurrent aprepitant

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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