Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047281
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2002-10-03
Brief Title:
Thalidomide Celecoxib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Trial Of Oral Thalidomide Celecoxib Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2017-07
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 Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma
PURPOSE Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma
Detailed Description:
OBJECTIVES
Determine the efficacy of thalidomide celecoxib etoposide and cyclophosphamide in terms of 6-month progression-free survival in patients with relapsed or refractory malignant glioma
Determine the overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the radiographic response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42 oral etoposide once daily on days 1-21 and oral cyclophosphamide once daily on days 22-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 48 patients 32 with glioblastoma multiforme and 16 with anaplastic glioma will be accrued for this study within 2 years
Determine the efficacy of thalidomide celecoxib etoposide and cyclophosphamide in terms of 6-month progression-free survival in patients with relapsed or refractory malignant glioma
Determine the overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the radiographic response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42 oral etoposide once daily on days 1-21 and oral cyclophosphamide once daily on days 22-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 48 patients 32 with glioblastoma multiforme and 16 with anaplastic glioma will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CELGENE-2001-P-0017573 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| CDR0000257584 | None | None | None |
| NCI-G02-2117 | None | None | None |