Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039364
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2002-06-06
Brief Title:
Imatinib Mesylate in Treating Patients With Gliomas
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Open Label Phase II Study On STI571 Glivec Administered As A Daily Oral Treatment In Gliomas
Status:
COMPLETED
Status Verified Date:
2012-07
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 interfere with the growth of tumor cells and slow the growth of the tumor
PURPOSE Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas
PURPOSE Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas
Detailed Description:
OBJECTIVES
Determine the therapeutic activity of imatinib mesylate in terms of objective response and progression-free survival at 6 months in patients with gliomas
Determine the safety of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to glioma glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma
Patients receive oral imatinib mesylate once or twice daily Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 77 patients 29 patients with glioblastoma multiforme 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma will be accrued for this study
Determine the therapeutic activity of imatinib mesylate in terms of objective response and progression-free survival at 6 months in patients with gliomas
Determine the safety of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to glioma glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma
Patients receive oral imatinib mesylate once or twice daily Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 77 patients 29 patients with glioblastoma multiforme 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma 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 |
|---|---|---|---|
| EORTC-26013 | None | None | None |
| EORTC-16011 | None | None | None |