Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003304
Status:
COMPLETED
Last Update Posted:
2012-03-06
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:
Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-03
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 following combination chemotherapy
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy
Detailed Description:
OBJECTIVES I Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazinelomustinevincristine PCV chemotherapy II Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients
OUTLINE This is an open label multicenter trial Temozolomide is administered orally on days 1-5 of each 4-week course treatment continues for a maximum of 12 courses Patients are followed every 2 months for the first 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 16-29 patients will be accrued for this study
OUTLINE This is an open label multicenter trial Temozolomide is administered orally on days 1-5 of each 4-week course treatment continues for a maximum of 12 courses Patients are followed every 2 months for the first 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 16-29 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-26972 | None | None | None |