Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma
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.
Mantle Cell Lymphoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Complete response and overall response rate [ Time Frame: After treatment ] [ Designated as safety issue: No ]
- Long- and short-term toxicity [ Time Frame: During and after treatment ] [ Designated as safety issue: Yes ]
- Cytokine profiles [ Time Frame: After treatment ] [ Designated as safety issue: No ]
- Prognostic importance of Aurora kinase A [ Time Frame: After treatment ] [ Designated as safety issue: No ]
- Prognostic importance of major carcinogenic pathways [ Time Frame: After treatment ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: VCR (Velcade, Cladribine and Rituximab)
375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
Other Name: RituxanDrug: bortezomib
1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
Other Name: VelcadeDrug: cladribine
4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
- Determine the 2-year progression-free survival of patients with advanced mantle cell lymphoma or indolent lymphoma treated with bortezomib, cladribine, and rituximab.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980395
|Contact: Ruth Cañamar, BAfirstname.lastname@example.org|
|Contact: Ellen Chase, BSemail@example.com|
|United States, Arizona|
|University of Arizona Cancer Center||Recruiting|
|Tucson, Arizona, United States, 85724-5024|
|Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008|
|Principal Investigator:||Thomas P. Miller, MD||University of Arizona|