Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004204
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2000-01-21
Brief Title:
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
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 113001 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 113001 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:
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 |
|---|---|---|---|
| SPRI-CPMC-IRB-8622 | None | None | None |
| CPMC-IRB-8622 | None | None | None |