Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor
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.
|Brain and Central Nervous System Tumors||Drug: temozolomide Drug: thalidomide||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme|
|Study Start Date:||May 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006358
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94115-0128|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Morris D. Groves, MD, JD||M.D. Anderson Cancer Center|