NCT00703664

Bortezomib and Vorinostat in Treating Patients With Recurrent Mantle Cell Lymphoma or Recurrent and/or Refractory Diffuse Large B-Cell Lymphoma

Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well bortezomib and vorinostat work in treating patients with recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

This was a multicenter, non-randomized phase 2 trial using a Simon two-stage design with 3 cohorts. PRIMARY OBJECTIVES: I. Estimate the response rates of mantle cell and diffuse large B-cell lymphomas to bortezomib and vorinostat combination therapy. SECONDARY OBJECTIVES: I. Assess the safety and tolerability of the study regimen. II. Observe progression-free survival and response durations. III. Observe the relationship between pretreatment lymphoma cell nuclear v-rel reticuloendotheliosis viral oncogene homolog A (relA) and response. OUTLINE: Patients receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Patients also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

• Recurrent Mantle Cell Lymphoma
• Recurrent Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib: 1.3 mg/m\^2/d IV days 1, 4, 8, and 11.
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Vorinostat	Vorinostat: 400 mg (total daily dose as a single dose) days 1-5 and 8-12.

Timeline

• Start date: 2008-07-09
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2008-06-23
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

12 sites across 1 country: United States