Spots Global Cancer Trial Database for Temozolomide in Treating Patients With Brain Metastases
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Trial Identification
Brief Title: Temozolomide in Treating Patients With Brain Metastases
Official Title: Phase II Treatment of Adults With Brain Metastases With Temodar
Study ID: NCT00005954
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Contact Details
Name: Henry S. Friedman, MD
Affiliation: Duke University
Role: STUDY_CHAIR
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