Clinical Trial: Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
  • Determine histological response in patients treated with this drug.

Secondary

  • Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
  • Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.

After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.


Sponsor: Technische Universität München

Current Primary Outcome: Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Original Primary Outcome:

Current Secondary Outcome:

  • Time to progression of disease
  • Overall survival


Original Secondary Outcome:

Information By: Technische Universität München

Dates:
Date Received: June 2, 2005
Date Started: February 2005
Date Completion:
Last Updated: March 7, 2012
Last Verified: March 2012