Depsipeptide in Treating Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||August 1997|
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 months.
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Susan E. Bates, MD||National Cancer Institute (NCI)|