Brain and Central Nervous System Tumors Clinical Trial
Official title:
Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood
flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from
dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and
cyclophosphamide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib
with etoposide and cyclophosphamide in treating patients who have relapsed or refractory
malignant glioma.
OBJECTIVES:
- Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in
terms of 6-month progression-free survival, in patients with relapsed or refractory
malignant glioma.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the radiographic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42,
oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42.
Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with
anaplastic glioma) will be accrued for this study within 2 years.
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