Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Treating Patients With Stage III or Stage IV Follicular Lymphoma or Marginal Zone Lymphoma
RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)|
- Overall Response Rate, According to the International Workshop Criteria (IWC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Progression-free Survival as Assessed by RECIST Criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles
Other Name: RituxanDrug: Bortezomib
1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
Other Name: VelcadeDrug: Cyclophosphamide
750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
Other Name: CytoxanDrug: Prednisone
100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
- To determine the overall response rate, in terms of complete response (CR), unconfirmed CR, and partial response, in patients with follicular lymphoma or marginal zone lymphoma treated with rituximab, cyclophosphamide, bortezomib, and prednisone (R-CVelP) as first line of treatment.
- To determine progression-free survival of patients treated with this regimen.
- To determine overall survival of patients treated with this regimen.
- To determine the safety and tolerance to R-CVelP in these patients.
- Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772668
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Denise Pereira, MD||University of Miami Sylvester Comprehensive Cancer Center|