Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma

• Status: Completed
• Trial end date: 2009-10-01
• 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma

• No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site

• Metastatic tumors of parameningeal sites eligible

• Bidimensionally measurable disease

• No positive cerebrospinal fluid cytology or multiple intracranial metastases

• Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy:

• Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy

• Tumor that touches or displaces the spinal cord

• Evidence of intracranial primary tumor extension

• Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate

• Requires emergency radiotherapy

• Lab values are consistent with disseminated intravascular coagulation

PATIENT CHARACTERISTICS:

Age:

• Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients)

• 10 to 49 (embryonal histology patients)

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

• Absolute neutrophil count greater than 1,000/mm^3*

• Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of bone marrow

Hepatic:

• Bilirubin less than 1.5 mg/dL

• PT, PTT, and fibrinogen less than 1.5 times upper limit of normal

Renal:

• Creatinine less than 1.2 mg/dL

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior steroids allowed

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy

Surgery:

• No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis