At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed supratentorial glioblastoma multiforme
- ✓Biopsy or subtotal/gross total resection of tumor
- ✓Completed post-operative radiotherapy within past 5 weeks with no progressive disease
- ✓Age 18 and over
- ✕History of allergic reactions to celecoxib, sulfonamides, aspirin, or other NSAIDs
- ✕Inflammatory bowel disease, peptic ulcer disease, or gastrointestinal bleeding within past 3 months
- ✕Active infection
- ✕Prior chemotherapy other than temozolomide with radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Celecoxib, Isotretinoin, and 2 other interventions for Brain and Central Nervous System Tumors and Glioblastoma Multiforme. Completed, enrolled 178 participants across 12 sites.
Detailed 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 body's 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.
Study Details
Timeline
Interventions
400 mg orally twice a day continuous dosing
40 mg/m\^2 orally twice a day (total daily dose = 80 mg/m\^2) days 1-21 of a 28 day cycle.
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)