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) to FR901228 in patients with relapsed
or refractory mantle cell or diffuse large cell non-Hodgkin's lymphoma.
II. Evaluate the safety and feasibility of FR901228, in terms of the incidence of toxicity
and maximum grade observed and courses delayed or dose reductions, in these patients.
III. Determine 2-year progression-free and overall survival.
OUTLINE: Patients receive FR901228 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.
After completion of study treatment, patients are followed every 3-6 months for up to 5
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.
24 weeks (6 courses of 4 week cycles)
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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