Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Rituximab; bortezomib
Intervention description: 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.; 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.
Intervention MeSH terms: Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma

          -  Life expectancy > 12 months

        Exclusion Criteria:

          -  No known history of HIV infection

          -  No other active infection

          -  No peripheral neuropathy ≥ grade 2 within the past 14 days

          -  No uncontrolled hypertension

          -  None of the following cardiac conditions:

               -  Myocardial infarction within the past 6 months

               -  No heart failure

               -  Uncontrolled angina

               -  Severe uncontrolled ventricular arrhythmias

               -  Electrocardiographic evidence of acute ischemia

               -  Active conduction system abnormalities

          -  No serious medical or psychiatric illness that would preclude study compliance

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior therapy for non-Hodgkins lymphoma

          -  No prior bortezomib or rituximab

          -  At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic
             anticancer biologic therapy, or anticancer hormonal therapy

          -  At least 2 weeks since prior investigational drugs

          -  No other concurrent systemic cytotoxic chemotherapy or investigational agents + No
             leukemia