Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-31 @ 12:14 AM
Study NCT ID:
NCT00004204
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2000-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
Detailed Description:
OBJECTIVES:
* Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
* Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
* Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme \[closed to accrual 11/30/01\] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
* Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
* Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
* Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme \[closed to accrual 11/30/01\] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: