RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.
OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC. OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased. PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Beckman Research Institute, City of Hope
Duarte, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Los Angeles County-University of Southern California Medical Center
Los Angeles, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
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