Phase II Trial of Gleevec (Formerly Known as STI571) in Patients With Soft Tissue and Bone Sarcomas: A Multi-Disciplinary Trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society

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