Brain and Central Nervous System Tumors Clinical Trial
Official title:
Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the
growth of the tumor.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients
who have gliomas.
OBJECTIVES:
- Determine the therapeutic activity of imatinib mesylate (in terms of objective response
and progression-free survival at 6 months) in patients with gliomas.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to glioma
(glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs
anaplastic astrocytoma or recurrent low-grade astrocytoma).
Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks
for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24
patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with
anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.
;
Primary Purpose: Treatment
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