Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400816
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2006-11-16
Brief Title:
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
Status:
COMPLETED
Status Verified Date:
2018-01
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 such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma
PURPOSE This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma
Detailed Description:
OBJECTIVES
Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma AO or mixed oligoastrocytoma MOA treated with temozolomide
Determine the response rate in these patients
Assess the quality of life of patients with AO or MOA treated with this regimen
OUTLINE This is a parallel-group multicenter study Patients are stratified according to disease type anaplastic oligodendroglioma vs mixed oligoastrocytoma
Patients receive oral temozolomide once daily on days 1-7 and 15-21 Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before courses 1 3 5 and 7 every 3 months for the first year after completion of treatment every 4 months for the second year every 6 months for the third and fourth years and once a year thereafter
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma AO or mixed oligoastrocytoma MOA treated with temozolomide
Determine the response rate in these patients
Assess the quality of life of patients with AO or MOA treated with this regimen
OUTLINE This is a parallel-group multicenter study Patients are stratified according to disease type anaplastic oligodendroglioma vs mixed oligoastrocytoma
Patients receive oral temozolomide once daily on days 1-7 and 15-21 Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before courses 1 3 5 and 7 every 3 months for the first year after completion of treatment every 4 months for the second year every 6 months for the third and fourth years and once a year thereafter
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | httpsreporternihgovquickSearchP30CA043703 |