Lymphoma Clinical Trial
Official title:
A Phase II, Open-Label Study of Bortezomib (Velcade), Cladribine and Rituximab (VCR) in Advanced, Newly Diagnosed and Relapsed/Refractory Mantle Cell and Indolent Lymphomas
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cladribine, 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 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 cancer-killing substances to them. Giving bortezomib together with
cladribine and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine
and rituximab works in treating patients with advanced mantle cell lymphoma or indolent
lymphoma.
OBJECTIVES:
Primary
- Determine the 2-year progression-free survival of patients with advanced mantle cell
lymphoma or indolent lymphoma treated with bortezomib, cladribine, and rituximab.
Secondary
- Determine the 2-year overall survival of patients treated with this regimen.
- Determine the complete response and overall response rate in patients treated with this
regimen.
- Describe the long- and short-term toxicity of this regimen in these patients.
- Determine the prognostic importance of Aurora kinase A in patients treated with this
regimen.
- Determine the cytokine profiles for each lymphoma subtype and how they change with this
regimen.
- Evaluate the prognostic importance of major carcinogenic pathways using tissue
microarray.
OUTLINE: Patients receive bortezomib IV on days 1 and 4, cladribine IV over 2 hours on days
1-5, and rituximab IV on day 1. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and after course 1 for cytokine profile studies.
Previously collected tissue samples are obtained for analysis of Aurora kinase A and B,
Ki-67, cyclin D, Bcl-2, phosphor-HisH3, c-Met, and VEGF expression by using tissue microarray
(IHC staining), reverse transcriptase-PCR, and/or western blotting.
After completion of study therapy, patients are followed up every 3 months for 2 years.
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