Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112502
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2005-06-02
Brief Title:
Temozolomide Alone or in Combination With Thalidomide andor Isotretinoin andor Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Factorial-Design Phase II Trial of Temozolomide Alone and in Combination With Possible Permutations of Thalidomide Isotretinoin andor Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2021-09
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 Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor Isotretinoin may help cells that are involved in the bodys immune response to work better Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known which temozolomide-containing regimen is more effective in treating glioblastoma multiforme
PURPOSE This randomized phase II trial is studying eight different temozolomide-containing regimens to compare how well they work in treating patients who have undergone radiation therapy for glioblastoma multiforme
PURPOSE This randomized phase II trial is studying eight different temozolomide-containing regimens to compare how well they work in treating patients who have undergone radiation therapy for glioblastoma multiforme
Detailed Description:
OBJECTIVES
Compare the efficacy of adjuvant temozolomide TMZ alone or in combination with thalidomide andor isotretinoin andor celecoxib in terms of 6-month progression-free survival in patients who have undergone radiotherapy for supratentorial glioblastoma multiforme
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 8 treatment arms
Arm I Patients receive oral temozolomide once daily on days 1-7 and 15-21
Arm II Patients receive temozolomide as in arm I and oral thalidomide once daily on days 1-28
Arm III Patients receive temozolomide as in arm I and oral isotretinoin twice daily on days 1-21
Arm IV Patients receive temozolomide as in arm I and oral celecoxib twice daily on days 1-28
Arm V Patients receive temozolomide as in arm I thalidomide as in arm II and isotretinoin as in arm III
Arm VI Patients receive temozolomide as in arm I thalidomide as in arm II and celecoxib as in arm IV
Arm VII Patients receive temozolomide as in arm I isotretinoin as in arm III and celecoxib as in arm IV
Arm VIII Patients receive temozolomide as in arm I thalidomide as in arm II isotretinoin as in arm III and celecoxib as in arm IV
In all arms treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patient may receive additional courses of therapy at the discretion of the treating physician
After completion of study treatment patients are followed for at least 30 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 180 patients will be accrued for this study
Compare the efficacy of adjuvant temozolomide TMZ alone or in combination with thalidomide andor isotretinoin andor celecoxib in terms of 6-month progression-free survival in patients who have undergone radiotherapy for supratentorial glioblastoma multiforme
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 8 treatment arms
Arm I Patients receive oral temozolomide once daily on days 1-7 and 15-21
Arm II Patients receive temozolomide as in arm I and oral thalidomide once daily on days 1-28
Arm III Patients receive temozolomide as in arm I and oral isotretinoin twice daily on days 1-21
Arm IV Patients receive temozolomide as in arm I and oral celecoxib twice daily on days 1-28
Arm V Patients receive temozolomide as in arm I thalidomide as in arm II and isotretinoin as in arm III
Arm VI Patients receive temozolomide as in arm I thalidomide as in arm II and celecoxib as in arm IV
Arm VII Patients receive temozolomide as in arm I isotretinoin as in arm III and celecoxib as in arm IV
Arm VIII Patients receive temozolomide as in arm I thalidomide as in arm II isotretinoin as in arm III and celecoxib as in arm IV
In all arms treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patient may receive additional courses of therapy at the discretion of the treating physician
After completion of study treatment patients are followed for at least 30 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 180 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 |
|---|---|---|---|
| MDA-ID-02586 | None | None | None |
| NCI-6636 | None | None | None |
| MDA-2004-0662 | None | None | None |
| CDR0000432954 | OTHER | None | None |
| NCI-2009-00076 | REGISTRY | NCI CTRP | None |