Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of Imatinib Mesylate in Combination With Temozolomide in Patients With Malignant Glioma
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving imatinib mesylate together with temozolomide may kill more tumor
cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate
when given together with temozolomide in treating patients with malignant glioma.
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity, if attainable, of
imatinib mesylate in combination with temozolomide in patients with malignant glioma.
- Characterize the safety and tolerability of imatinib mesylate, including acute and
chronic toxicities, in these patients.
- Determine the effect of temozolomide on the pharmacokinetics (PK) of imatinib mesylate
at each dose level.
- Evaluate the impact of enzyme-inducing anti-epileptic drug (EIAED) coadministration on
the PK of imatinib mesylate using a population-based PK approach.
- Evaluate the antitumor activity of imatinib mesylate plus temozolomide.
OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients are stratified
according to concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital,
carbamazepine, fosphenytoin, primidone, oxcarbazepine) (yes vs no).
Patients receive oral imatinib mesylate once or twice daily on days 1-8 and oral
temozolomide once daily on days 4-8. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of imatinib mesylate until the maximum
tolerated dose is determined.
On days 1 and 8 of course 1, blood is drawn for pharmacokinetic studies.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
;
Primary Purpose: Treatment
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