Gastrointestinal Stromal Tumor Clinical Trial
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-Derived Growth Factor Receptor-alpha
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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