A Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma
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
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
Patients are followed every 3 months until disease progression and then every 6 months until
5 years from study registration.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nancy L. Bartlett, MD
Washington University Siteman Cancer Center
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Howard University Cancer Center at Howard University Hospital||Washington, District of Columbia 20060|