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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Lee J. Helman, MD
Study Chair
National Cancer Institute (NCI)
United States: Federal Government
CDR0000069239
NCT00031915
June 2002
May 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
Washington Hospital Center | Washington, District of Columbia 20010 |