Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Dactinomycin; Doxorubicin; Etoposide; Lenograstim; Liposomal doxorubicin; Sargramostim; Sulfamethoxazole; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Wilms' tumor

• Eligible subtypes:

• Favorable histologies

• Anaplastic histologies

• Clear cell sarcoma of the kidney

• Rhabdoid tumor of the kidney

• Relapsed disease after entry on protocol NWTS-5 (NWTS-Q9401)

PATIENT CHARACTERISTICS:

Age:

• 21 and under at original diagnosis

Performance status:

• Not specified

Life expectancy:

• At least 4 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times normal

• SGOT or SGPT less than 2.5 times normal

Renal:

• Creatinine no greater than 1.5 times normal OR

• Creatinine clearance or GFR at least 70 mL/min

Cardiovascular:

• Shortening fraction at least 27% by echocardiogram OR

• Ejection fraction greater than 50% by echocardiogram or MUGA scan

Other:

• Not pregnant

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 2 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior therapy for relapsed Wilms' tumor

• Recovered from the toxic effects of any other prior therapy