Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049127
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2002-11-12
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Trial of Imatinib Mesylate Gleevec STI571 in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma
Status:
COMPLETED
Status Verified Date:
2019-10
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:
This phase III trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To identify the maximum tolerated dose of imatinib imatinib mesylate in patients with recurrent oligodendroglioma and mixed oligoastrocytoma that are currently on enzyme inducing anticonvulsant therapy Study 1 II To assess the efficacy of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas with pathologic evidence of oligodendrogliomatous component as measured by progression-free survival response and overall survival Study 2 III To acquire pilot data on a patient group not traditionally eligible for recurrent oligodendroglioma and mixed oligoastrocytoma clinical trials those having 2 prior chemotherapy regimens or 2 prior chemotherapy regimens for recurrentprogressive disease Study 3 IV To examine the toxicity and safety of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas with pathologic evidence of oligodendrogliomatous component Studies 1 2 and 3 V To perform a preliminary correlative study of 1p19q alterations alpha platelet-derived growth factor receptor PDFGR gene amplification and levels of related downstream signaling elements in tumor tissue with clinical study endpoints Studies 1 2 and 3 VI To perform a descriptive correlative analysis of steady state pharmacokinetic data regarding imatinib and active metabolites with the study endpoints Studies 1 2 and 3
OUTLINE This is a phase I dose-escalation study followed by a phase II and a pilot study
I To identify the maximum tolerated dose of imatinib imatinib mesylate in patients with recurrent oligodendroglioma and mixed oligoastrocytoma that are currently on enzyme inducing anticonvulsant therapy Study 1 II To assess the efficacy of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas with pathologic evidence of oligodendrogliomatous component as measured by progression-free survival response and overall survival Study 2 III To acquire pilot data on a patient group not traditionally eligible for recurrent oligodendroglioma and mixed oligoastrocytoma clinical trials those having 2 prior chemotherapy regimens or 2 prior chemotherapy regimens for recurrentprogressive disease Study 3 IV To examine the toxicity and safety of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas with pathologic evidence of oligodendrogliomatous component Studies 1 2 and 3 V To perform a preliminary correlative study of 1p19q alterations alpha platelet-derived growth factor receptor PDFGR gene amplification and levels of related downstream signaling elements in tumor tissue with clinical study endpoints Studies 1 2 and 3 VI To perform a descriptive correlative analysis of steady state pharmacokinetic data regarding imatinib and active metabolites with the study endpoints Studies 1 2 and 3
OUTLINE This is a phase I dose-escalation study followed by a phase II and a pilot 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 |
|---|---|---|---|
| U10CA025224 | NIH | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2011-01576 | REGISTRY | None | None |
| NCCTG-N0272 | None | None | None |
| CDR0000257812 | REGISTRY | None | None |