FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Mantle Cell Lymphoma||Drug: romidepsin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Depsipeptide, a Histone Deacetylase Inhibitor, in Relapsed or Refractory Mantle Cell or Diffuse Large Cell Non-Hodgkin's Lymphoma|
- Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment [ Time Frame: 24 weeks (6 courses of 4 week cycles) ]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.
- Median Progression Free-survival (PFS) [ Time Frame: 2 Years ]Time to disease progression is defined as the time from registration to documentation of disease progression.
- Median Overall Survival [ Time Frame: 5 Years ]Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.
|Study Start Date:||September 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.
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 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383565
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge Romaguera||M.D. Anderson Cancer Center|