NCT00851552

Bortezomib, Doxorubicin Hydrochloride Liposome, and Rituximab in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment

A Phase II Study of VDR (VELCADE™, DOXIL® and RITUXAN™) in Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving bortezomib together with doxorubicin hydrochloride liposome and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and rituximab works in treating patients with diffuse large B-Cell lymphoma that has relapsed or not responded to treatment.

Detailed description

OBJECTIVES: Primary * To determine the overall objective response rate (i.e., complete and partial response) in patients with relapsed or refractory, CD20-positive, diffuse large B-cell lymphoma treated with bortezomib, pegylated liposomal doxorubicin hydrochloride, and rituximab. Secondary * To assess the toxicity/safety profile associated with this regimen. * To conduct correlative translational research studies. OUTLINE: Patients receive bortezomib IV on days 1, 4, 8, and 11, pegylated liposomal doxorubicin hydrochloride IV on day 11, and rituximab IV on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Tissue and blood samples are collected periodically for correlative studies. Samples are analyzed for expression of CD11b/CD18, CD32, CD 33, CD62, CD64, CD69, and CD56 by flow cytometric analysis of neutrophils, NK cells, and monocytes; antibody-dependent cellular and complement-mediated cytotoxicity; and genotypic analysis of polymorphisms by PCR. Autologous neoplastic B-cells derived from tissue samples are used for genetic and protein profiling. After completion of study therapy, patients are followed periodically for 4 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	Given IV
DRUG	bortezomib	Given IV
DRUG	pegylated liposomal doxorubicin hydrochloride	Given IV
GENETIC	gene expression analysis	Correlative Study
GENETIC	polymerase chain reaction	Correlative Study
GENETIC	polymorphism analysis	Correlative Study
GENETIC	proteomic profiling	Correlative Study
OTHER	flow cytometry	Correlative Study
OTHER	laboratory biomarker analysis	Correlative Study

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-02-26
• Last updated: 2014-07-21
• Results posted: 2014-07-21

Locations

1 site across 1 country: United States