Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cactinomycin; Cyclophosphamide; Dactinomycin; Lenograstim; Sargramostim; Topotecan; Vincristine

Criteria

Inclusion Criteria:

• Histologically proven disease of any of the following types:

• Non metastatic alveolar rhabdomyosarcoma

• Stage I, II, or III; Clinical Group I, II, or III

• Stage II or III, Clinical Group III embryonal rhabdomyosarcoma

• Botryoid

• Spindle cell

• Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma

• Botryoid

• Spindle cell

• Undifferentiated sarcoma

• Stage I, II, or III; Clinical Group I, II, or III

• Ectomesenchymoma

• Stage I, II, or III; Clinical Group I, II, or III, with alveolar features

• Under 10 years, Stage IV, Clinical Group IV, with embryonal features

• No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis

• No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases

• Bilirubin no greater than 1.5 mg/dL

• Creatinine normal* for age

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior chemotherapy

• Prior steroids allowed

• No prior radiotherapy

• See Disease Characteristics