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 advanced solid tumors that have spread to the brain.
OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug. OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide
Time frame: 2 years
To assess the safety and tolerability of low dose, continuous oral temozolomide in this patient population
Time frame: 2 years
to measure quality of life in patients with cerebral metastases treated with low dose, continuous temozolomide
Time frame: 2 years
To measure the rate of response of systemic disease outside the central nervous system to extended low dose continuous oral temozolomide
Time frame: 2 years
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