Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma
Conditions
Keywords
metastatic osteosarcoma, recurrent childhood rhabdomyosarcoma, recurrent osteosarcoma, embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, pleomorphic childhood rhabdomyosarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood fibrosarcoma, childhood synovial sarcoma, childhood liposarcoma, childhood alveolar soft-part sarcoma, childhood neurofibrosarcoma, childhood angiosarcoma, childhood malignant fibrous histiocytoma of bone, previously treated childhood rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, fibrosarcomatous osteosarcoma
Brief summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.
Detailed description
OBJECTIVES: * Determine the efficacy of imatinib mesylate, as measured by response rate, in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens. * Determine the clinical and laboratory toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype. Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this study.
Interventions
DRUGimatinib mesylate
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma * Eligible subtypes: * Ewing's family (e.g., primitive neuroectodermal tumor) * Osteosarcoma * Synovial sarcoma * Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic) * Liposarcoma (all variants) * Malignant fibrous histiocytoma * Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma) * Fibrosarcoma * Angiosarcoma (all variants) * Failed standard therapy with no available salvage regimens * Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination * Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy PATIENT CHARACTERISTICS: Age: * 10 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 3 times upper limit of normal (ULN) * ALT and AST less than 2.5 times ULN Renal: * Creatinine less than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No hormonal birth control Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * At least 28 days since any prior systemic therapy
Countries
United States
Outcome results
None listed