Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT00772668
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
17 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Administered intravenously during induction and maintenance therapy per protocol.
  • Bortezomib — DRUG
    Administered intravenously per protocol.
  • Cyclophosphamide — DRUG
    Administered intravenously per protocol.
  • Prednisone — DRUG
    Administered orally (PO) per protocol.

Study Details

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.

Key Dates

Start date
Sep 25, 2009
Status verified
Nov 2017
Primary completion
Dec 31, 2010
Completion
Feb 28, 2011

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RCVELP
    Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Primary Outcome Measure

Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL) [ Time Frame: Post cycles 2,4,6,8 and then every 3 months, about 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Comprehensive Cancer Center - Miami· Miami, FL

Related Studies