Phase I Study of UCN-01 and Cytarabine (ARA-C) in Patients With Acute Myelogenous Leukemia, and Myelodysplastic Syndromes
OBJECTIVES: I. Determine the maximum tolerated dose of cytarabine when combined with UCN-01
in patients with refractory or relapsed acute myelogenous leukemia or myelodysplastic
syndrome. II. Determine the dose limiting toxicity, pharmacokinetics, and pharmacodynamics
of this regimen in these patients. III. Assess the antileukemia effect of this regimen in
this patient population.
OUTLINE: This is a dose escalation, multicenter study of cytarabine. Patients receive
cytarabine IV over 24 hours on days 1-4 of each course. Patients receive UCN-01 IV over 24
hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses.
Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) Cytarabine + UCN-01
4 week cycle
Jorge Cortes, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|