A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies
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.
Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|Beckman Research Institute, City of Hope||Los Angeles, California 91010|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Los Angeles County-University of Southern California Medical Center||Los Angeles, California 90033|