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A Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma
This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the response rate (complete and partial) in patients with relapsed or refractory Burkitt's, mantle cell or diffuse large cell non-Hodgkin's lymphoma treated with FR901228 (depsipeptide). II. Determine the safety and feasibility of this drug, in terms of incidence and maximum grade of toxicity and courses delayed or doses reduced, in these patients. III. Determine the 2-year progression-free survival and overall survival of patients treated with this drug. IV. Correlate tumor expression of BCL-2, BCL-6, BAX, and RAS with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Howard University Cancer Center at Howard University Hospital
Washington D.C., District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Start Date
January 1, 2004
Primary Completion Date
December 1, 2005
Last Updated
February 11, 2013
35
ACTUAL participants
romidepsin
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT07388563
NCT06337318
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