Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

Study Overview
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Brief Summary
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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

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and Rituximab in patients with recurrent B-cell NHL. SECONDARY OBJECTIVES: I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression. II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab on Bcl-2 protein gene expression. OUTLINE: Patients receive oblimersen sodium intravenously (IV) continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment. After completion of study treatment, patients are followed up every 3 months.

Official Title
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A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas

Conditions
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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

Intervention / Treatment
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* Biological: oblimersen sodium
* Biological: rituximab
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (oblimersen sodium and monoclonal antibody therapy)<br>Patients receive oblimersen sodium IV continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment. | Biological: oblimersen sodium<br>* Given IV<br>* Other names: Genasense;Biological: rituximab<br>* Given IV<br>* Other names: Rituxan;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Objective Response | Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment | 2 months following study treatment |