Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003465
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Treatment of Adults With Newly Diagnosed Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma 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 patients with anaplastic oligodendroglioma
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients with anaplastic oligodendroglioma
Detailed Description:
OBJECTIVES I Determine the activity of temozolomide in patients with newly diagnosed progressive or recurrent anaplastic oligodendroglioma II Determine the toxicity of this drug in this patient population
OUTLINE Patients are stratified according to disease characteristics newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma Patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days Patients with progressive or recurrent disease at baseline continue treatment in the absence of disease progression or unacceptable toxicity Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity Patients with responding disease may receive an additional 6 courses after completion of radiotherapy Radiotherapy is not part of study treatment Patients are followed every 8 weeks for 2 years
PROJECTED ACCRUAL A maximum of 60 patients 30 per stratum will be accrued for this study
OUTLINE Patients are stratified according to disease characteristics newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma Patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days Patients with progressive or recurrent disease at baseline continue treatment in the absence of disease progression or unacceptable toxicity Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity Patients with responding disease may receive an additional 6 courses after completion of radiotherapy Radiotherapy is not part of study treatment Patients are followed every 8 weeks for 2 years
PROJECTED ACCRUAL A maximum of 60 patients 30 per stratum 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 |
|---|---|---|---|
| CDR0000066501 | OTHER | NCI | None |
| DUMC-1534-00-8R3 | None | None | None |
| DUMC-1372-97-9 | None | None | None |
| DUMC-1403-98-9R1 | None | None | None |
| DUMC-1550-99-9R2 | None | None | None |
| DUMC-97104 | None | None | None |
| NCI-G98-1468 | None | None | None |