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
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
-
Given IV
- DRUG
-
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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