Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00354068|
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : March 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: imatinib mesylate Drug: temozolomide Other: pharmacological study||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Official Title:||A Phase I Study of Imatinib Mesylate in Combination With Temozolomide in Patients With Malignant Glioma|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
- Maximum tolerated dose
- Dose-limiting toxicity
- Safety and tolerability
- Anti-tumor activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354068
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|Study Chair:||David A. Reardon, MD||Duke Cancer Institute|