Clinical trial NCT00112502
Conditions: Brain and Central Nervous System Tumors Glioblastoma Multiforme
Keywords: adult giant cell glioblastoma adult gliosarcoma adult glioblastoma
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-09-01; Completion date: 2014-09-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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 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.

Detailed description:
OBJECTIVES:

* 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 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.

Arms: arm 1: Oral Temozolomide (TMZ) 150 mg/m\^2 once daily on days 1-7 and 15-21. arm 2: Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg). arm 3: Temozolomide as in Arm I and oral Isotretinoin 40 mg/m\^2 twice daily on days 1-21. arm 4: Temozolomide as in arm I and oral Celecoxib 400 mg twice daily on days 1-28. arm 5: Temozolomide as in arm I, Thalidomide as in arm II, and Isotretinoin as in arm III. arm 6: Temozolomide as in Arm I, Thalidomide as in Arm II, and Celecoxib as in Arm IV. arm 7: Temozolomide as in Arm I, Isotretinoin as in Arm III, and Celecoxib as in Arm IV. arm 8: Temozolomide as in Arm I, Thalidomide as in Arm II, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Interventions: intervention 1: Celecoxib intervention 2: Isotretinoin intervention 3: Temozolomide intervention 4: Thalidomide
Intervention descriptions: intervention 1: 400 mg orally twice a day continuous dosing intervention 2: 40 mg/m\^2 orally twice a day (total daily dose = 80 mg/m\^2) days 1-21 of a 28 day cycle. intervention 3: 150 mg/m2 orally daily, 7 days on treatment, 7 days off. intervention 4: 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)

Protocol documents: