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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, Germany
Universitaetsklinikum Bonn
Bonn, Germany
Overall tumor response (complete response, partial response, stable disease, and progression of disease)
Time to progression of disease
Overall survival
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Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany
University Medical Center Hamburg - Eppendorf
Hamburg, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany