Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
Condition: Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Testicular Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Waldenstrom Macroglobulinemia; Lymphomatoid Granulomatosis; Intraocular Lymphoma; Recurrence
Intervention: oblimersen sodium; rituximab; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Correlative studies
Intervention MeSH terms: Rituximab; Oblimersen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this clinical research study is to learn if the combination of oblimersen sodium
      and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell
      non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an
      investigational drug. The safety of this combination treatment will also be studied
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have recurrent B-cell NHL and measurable disease

          -  No anti-lymphoma therapy within the past 4 weeks

          -  Must have a good performance status (less than or equal to 2 Zubrod, greater than or
             equal to 60 Karnofsky)

          -  Absolute neutrophil count (ANC) greater than or equal to 1,000

          -  Platelets greater than or equal to 75,000

          -  Hemoglobin greater than or equal to 10 g/dL

          -  Bilirubin less than or equal to 1.5 mg/dL

          -  Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase
             (SGPT) less than or equal to 2 times upper limit of laboratory normals

          -  Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals

          -  Serum creatinine less than or equal to 1.8 mg/dL

          -  Must sign a consent form, and must have a life expectancy of greater than 12 weeks

          -  No more than 3 prior chemotherapy regimens

          -  Patients who are either Rituximab naive, have previously responded to Rituximab, or
             are refractory to Rituximab used alone or in combination with chemotherapy

        Exclusion Criteria:

          -  Human immunodeficiency virus (HIV) positive

          -  Active infection or history of opportunistic infections

          -  Pregnant women and women of childbearing age who are not practicing adequate
             contraception; men who are not willing to use an effective method of contraception

          -  History of second cancer (except for adequately treated basal cell or squamous cell
             skin cancer, in situ cervical cancer or other cancer for which the patient has been
             disease-free for 5 or more years)

          -  Active autoimmune disease

          -  Other significant medical diseases

          -  Patients with chronic lymphocytic leukemia (CLL)

          -  Prior exposure to G3139