Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354068
Status:
COMPLETED
Last Update Posted:
2013-03-28
First Post:
2006-07-19
Brief Title:
Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase I Study of Imatinib Mesylate in Combination With Temozolomide in Patients With Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000483760 | OTHER | NCI | None |
| DUMC-5514-06-1R2 | None | None | None |
| NOVARTIS-DUMC-5514-06-1R2 | None | None | None |