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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00031915

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma	Drug: imatinib mesylate	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2002

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
2	Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068
4	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
5	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
6	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
7	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
8	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021-6007
9	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
10	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009