Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003464
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
Status:
COMPLETED
Status Verified Date:
2009-10
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:
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 adults with newly diagnosed primary malignant glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme
Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients
Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide
OUTLINE Patients receive temozolomide orally once daily on days 1-5 Treatment courses are repeated every 28 days In the absence of disease progression and toxicity patients receive up to 4 courses of treatment prior to radiation therapy After radiation therapy patients demonstrating partial or complete response may receive an additional 12 courses of treatment
Patients are followed every 8-12 weeks for 2 years
PROJECTED ACCRUAL This study will accrue 50 patients
Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme
Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients
Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide
OUTLINE Patients receive temozolomide orally once daily on days 1-5 Treatment courses are repeated every 28 days In the absence of disease progression and toxicity patients receive up to 4 courses of treatment prior to radiation therapy After radiation therapy patients demonstrating partial or complete response may receive an additional 12 courses of treatment
Patients are followed every 8-12 weeks for 2 years
PROJECTED ACCRUAL This study will accrue 50 patients
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 |
|---|---|---|---|
| CDR0000066498 | OTHER | NCI | None |
| DUMC-1171-01-6R4 | None | None | None |
| DUMC-1016-97-7 | None | None | None |
| DUMC-1056-98-7R1 | None | None | None |
| DUMC-1058-98-7R1 | None | None | None |
| DUMC-1171-00-6R3 | None | None | None |
| DUMC-1231-99-7R2 | None | None | None |
| DUMC-97081 | None | None | None |
| NCI-G98-1465 | None | None | None |