Clinical Trial: Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Treating Patients With Stage III or Stage IV Follicular Lymphoma or Marginal Zone Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

OUTLINE:

  • 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.


Sponsor: University of Miami

Current Primary Outcome: Overall Response Rate, According to the International Workshop Criteria (IWC) [ Time Frame: 5 years ]

Original Primary Outcome: Overall Response Rate, According to the International Workshop Criteria (IWC)

Current Secondary Outcome:

  • Progression-free Survival as Assessed by RECIST Criteria [ Time Frame: 5 years ]
  • Overall Survival [ Time Frame: 5 years ]
  • Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Progression-free Survival as Assessed by RECIST Criteria
  • Overall Survival
  • Safety and tolerance to rituximab, cyclophosphamide, bortezomib and prednisone


Information By: University of Miami

Dates:
Date Received: October 12, 2008
Date Started: September 2008
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016