Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to
the tumor.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide
in treating patients who have recurrent or progressive brain tumor.
OBJECTIVES: I. Determine the efficacy of temozolomide and thalidomide in patients with
recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma. II. Determine
the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days
1-5 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of
24 courses in the absence of disease progression or unacceptable toxicity. Patients are
followed at 1 month and then for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 months.
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