Bortezomib, Doxorubicin Hydrochloride Liposome, and Rituximab in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment
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|ClinicalTrials.gov Identifier: NCT00851552|
Recruitment Status : Terminated (Lack of sponsor support)
First Posted : February 26, 2009
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: bortezomib Drug: pegylated liposomal doxorubicin hydrochloride Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Genetic: proteomic profiling Other: flow cytometry Other: laboratory biomarker analysis||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of VDR (VELCADE™, DOXIL® and RITUXAN™) in Relapsed/Refractory Diffuse Large B-cell Lymphoma|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
- Biological: rituximab
- Drug: bortezomib
- Drug: pegylated liposomal doxorubicin hydrochloride
- Genetic: gene expression analysis
- Genetic: polymerase chain reaction
- Genetic: polymorphism analysis
- Genetic: proteomic profiling
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21 [ Time Frame: at weeks 9 and 21 ]
- Safety [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851552
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Myron S. Czuczman, MD||Roswell Park Cancer Institute|