Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

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