NCT00025246

Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery

A Phase II Study of Adjuvant STI571 (Gleevec TM) Therapy in Patients Following Completely Resected High-risk Primary GastroIntestinal Stromal Tumor (GIST)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth

Detailed description

PRIMARY OBJECTIVES: I. To ascertain whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with STI571 have prolonged survival compared to historical controls. SECONDARY OBJECTIVES: I. To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant STI571 following complete resection of high-risk primary GIST. II. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and at the time of recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and at the time of recurrence) for scientific correlative analyses. III. To assess the toxicity of oral STI571 therapy when used in the adjuvant setting. OUTLINE: Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 10 years.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-09-01
• Primary completion: 2007-11-01
• First posted: 2003-01-27
• Last updated: 2013-02-20

Locations

1 site across 1 country: United States