A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination With Possible Permutations of Thalidomide, Isotretinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
- Compare the efficacy of adjuvant temozolomide (TMZ) alone or in combination with
thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free
survival, in patients who have undergone radiotherapy for supratentorial glioblastoma
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 8
- 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
- Arm III: Patients receive temozolomide as in arm I and oral isotretinoin twice daily on
- Arm IV: Patients receive temozolomide as in arm I and oral celecoxib twice daily on
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression-free survival at 6 months
Number of participants with no disease progression, measured at 6 months. A combination of the neurological examination and MRI brain scan used to define progression.
Mark R. Gilbert, MD
M.D. Anderson Cancer Center
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|M.D. Anderson Cancer Center at Orlando||Orlando, Florida 32806|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Hembree Mercy Cancer Center at St. Edward Mercy Medical Center||Ft. Smith, Arkansas 72903|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|