Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003466
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
1999-11-01
Brief Title:
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
Status:
COMPLETED
Status Verified Date:
2013-02
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma
PURPOSE This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma
Detailed Description:
OBJECTIVES
Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide
Determine the activity of this drug in terms of stabilizing growth of progressive low-grade gliomas in adult patients
OUTLINE Patients are stratified by disease type pilocytic astrocytoma mixed glioma well-differentiated oligodendroglioma and nonbiopsied optic pathway glioma or pontine glioma
Patients receive temozolomide orally once daily on days 1-5 Courses repeat every 28 days In the absence of disease progression or unacceptable toxicity patients may continue with treatment until tumor has remained stable for 12 courses
Patients are followed every 8-12 weeks for 2 years
PROJECTED ACCRUAL A total of 36-100 patients 9-25 per stratum will be accrued for this study within 3 years
Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide
Determine the activity of this drug in terms of stabilizing growth of progressive low-grade gliomas in adult patients
OUTLINE Patients are stratified by disease type pilocytic astrocytoma mixed glioma well-differentiated oligodendroglioma and nonbiopsied optic pathway glioma or pontine glioma
Patients receive temozolomide orally once daily on days 1-5 Courses repeat every 28 days In the absence of disease progression or unacceptable toxicity patients may continue with treatment until tumor has remained stable for 12 courses
Patients are followed every 8-12 weeks for 2 years
PROJECTED ACCRUAL A total of 36-100 patients 9-25 per stratum will be accrued for this study within 3 years
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 |
|---|---|---|---|
| DUMC-1703-02-9R5 | None | None | None |
| DUMC-1703-04-12R7 | None | None | None |
| DUMC-000693-01-3R1 | None | None | None |
| DUMC-1703-01-94R | None | None | None |
| DUMC-1502-97-10 | None | None | None |
| DUMC-1569-98-10R1 | None | None | None |
| DUMC-97125 | None | None | None |
| NCI-G98-1469 | None | None | None |