NCT00383565

FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase II Study of Depsipeptide, a Histone Deacetylase Inhibitor, in Relapsed or Refractory Mantle Cell or Diffuse Large Cell Non-Hodgkin's Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell to grow and by blocking blood flow to the cancer. This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: 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.

Conditions

• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2006-10-03
• Last updated: 2014-05-20
• Results posted: 2012-08-22

Locations

1 site across 1 country: United States