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
- 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.
- 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
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Overall tumor response (complete response, partial response, stable disease, and progression of disease)
Thomas Licht, MD
Technische Universität München
Germany: Federal Institute for Drugs and Medical Devices