NCT00354068

Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma

A Phase I Study of Imatinib Mesylate in Combination With Temozolomide in Patients With Malignant Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	imatinib mesylate
DRUG	temozolomide
OTHER	pharmacological study

Timeline

• Start date: 2004-07-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2006-07-20
• Last updated: 2013-03-28

Locations

1 site across 1 country: United States