Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients With Refractory Neoplasms
OBJECTIVES: I. Determine the toxic effects and the maximum tolerated dose (MTD) of
depsipeptide in patients with incurable solid tumors (per 3/29/00 notification, only
patients with cutaneous T-cell lymphoma are being accrued). II. Determine antineoplastic
activity of depsipeptide in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients receive depsipeptide IV over
4 hours on days 1 and 5. Treatment continues every 21 days in the absences of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
depsipeptide. If 2 of 6 patients experience dose-limiting toxicity at a given dose level,
escalation ceases and the maximum tolerated dose is defined as the previous dose level .
PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for this study within 18-24
Primary Purpose: Treatment
Susan E. Bates, MD
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|