A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)
- Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with
chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or
acute lymphoblastic leukemia.
- Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these
- Determine any preliminary anti-tumor activity of this drug in these patients.
OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to
disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid
leukemia and acute lymphoblastic leukemia).
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment
repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable
Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal
active dose is determined. If 5 or more patients show clinical or biological response, the
subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the
subsequent cohort is treated at a higher dose.
PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.
Primary Purpose: Treatment
Guido Marcucci, MD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|