Temozolomide in Treating Patients With Brain Metastases
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Treatment of Adults With Brain Metastases With Temodar|
|Study Start Date:||August 2000|
|Study Completion Date:||June 2003|
- Determine the activity of temozolomide in patients with brain metastases.
- Determine the toxicity of this treatment in these patients.
OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).
Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|