Lymphoma Clinical Trial
Official title:
A Phase II Study of VDR (VELCADE™, DOXIL® and RITUXAN™) in Relapsed/Refractory Diffuse Large B-cell Lymphoma
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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