This phase II trial is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES: I. Determine the complete and partial response rate in patients with relapsed or refractory acute myeloid leukemia treated with FR901228 (depsipeptide). II. Determine the toxicity of this drug in these patients. III. Correlate clinical response with specific cytogenetic abnormalities in patients treated with this drug. OUTLINE: Patients are stratified according to the presence of a specific chromosomal abnormality (t\[8;21\] vs inv 16 vs t\[15;17\] vs absence of these chromosomal abnormalities). Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Given IV
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Vanderbilt University
Nashville, Tennessee, United States
Response rate (complete and partial)
Time frame: Up to 7 years
Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 7 years
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