Clinical Trial: Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Oncol
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.
Detailed Summary:
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.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: March 8, 2002
Date Started: June 2002
Date Completion:
Last Updated: June 17, 2013
Last Verified: October 2003
