Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

Part of paid clinical trials in Miami, Florida.

Sponsor
Northwestern University
Study ID
NCT00369707
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
  • bortezomib — DRUG
    On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.

Study Details

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 cancer. 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 rituximab may kill more cancer cells. This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.

Key Dates

Start date
Aug 9, 2006
Status verified
Oct 2018
Primary completion
May 22, 2012
Completion
Oct 10, 2014

Study Design

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

Arms

  • Experimental: Bortezomib and Rituximab
    On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.

Primary Outcome Measure

Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment. [ Time Frame: At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days. ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiamiFlorida33136-
Hematology-Oncology Associates of IllinoisChicagoIllinois60611-2998-
Northwestern UniversityChicagoIllinois60611-
Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvania19111-2497-

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Comprehensive Cancer Center - Miami· Miami, FLHematology-Oncology Associates of Illinois· Chicago, ILNorthwestern University· Chicago, ILFox Chase Cancer Center - Philadelphia· Philadelphia, PA

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