Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma
I. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free
survival, of patients with recurrent meningioma.
II. Determine the response rate and overall survival of patients treated with this drug.
III. Evaluate the safety profile of this drug in these patients. IV. Determine the
pharmacokinetics of this drug in these patients. V. Determine the surrogate endpoints of
angiogenic activity of this drug in these patients.
VI. Correlate molecular abnormalities in the tumor with response in patients treated with
OUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of
enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or
malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs
Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study
within 8-12 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival according to Response Evaluation Criteria In Solid Tumors Group (RECIST)
At 6 months
North American Brain Tumor Consortium
United States: Food and Drug Administration
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