A PHASE I STUDY OF DEPSIPEPTIDE (NSC#630176, IND# 51810) IN PEDIATRIC PATIENTS WITH REFRACTORY SOLID TUMORS AND LEUKEMIAS
I. Determine the maximum tolerated dose (MTD) of FR901228 (depsipeptide) in pediatric
patients with refractory or recurrent solid tumors.
II. Determine the dose-limiting toxic effects of this drug in these patients. III. Determine
the pharmacokinetics of this drug in these patients. IV. Assess tolerability of this drug at
the solid tumor MTD in patients with refractory or recurrent leukemia.
V. Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients with solid tumors receive escalating doses of FR901228 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Cohorts of 3 patients (6 patients total) with leukemia receive FR901228 as above at the MTD.
Patients are followed for survival.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD, defined as that dose at which fewer than one-third of patients experience DLT, graded according to the NCI CTC version 2.0
Up to 28 days
Children's Oncology Group
United States: Food and Drug Administration
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