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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031915
• Other study ID #: CDR0000069239
• Secondary ID: NCI-02-C-0097CCU
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2002
• Last updated: June 17, 2013
• Start date: June 2002
• Est. completion date: May 2007

Study information

• Verified date: October 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00029094

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Malignant Fibrous Histiocytoma of Bone
• Histiocytoma
• Histiocytoma, Malignant Fibrous
• Osteosarcoma
• Sarcoma

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. — View Citation