Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047294
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2002-10-03
Brief Title:
Temozolomide Thalidomide and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study Of Temozolomide Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
Status:
COMPLETED
Status Verified Date:
2005-05
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 Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of combining temozolomide thalidomide and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of combining temozolomide thalidomide and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the efficacy of adjuvant temozolomide thalidomide and celecoxib after radiotherapy in terms of time to tumor progression and overall survival in patients with newly diagnosed glioblastoma multiforme
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and oral celecoxib twice daily on days 1-28 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
Determine the efficacy of adjuvant temozolomide thalidomide and celecoxib after radiotherapy in terms of time to tumor progression and overall survival in patients with newly diagnosed glioblastoma multiforme
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and oral celecoxib twice daily on days 1-28 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
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-2000-P-0025211 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| CDR0000257587 | None | None | None |
| NCI-G02-2118 | None | None | None |