Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003731
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors a Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-09
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 patients with recurrent oligodendroglial tumors
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors
Detailed Description:
OBJECTIVES I Assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy II Assess the objective response and duration of response of these patients given this treatment III Characterize the acute side effects of temozolomide in this patient population
OUTLINE This is an open label multicenter study Patients receive oral temozolomide on days 1-5 Courses are repeated every 28 days Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 15-33 patients will be accrued for this study
OUTLINE This is an open label multicenter study Patients receive oral temozolomide on days 1-5 Courses are repeated every 28 days Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 15-33 patients 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-26971 | None | None | None |