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

NCT00851552 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-07-21

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY
  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Myron S. Czuczman, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00851552 on ClinicalTrials.gov