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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Waldenström Macroglobulinemia; Recurrent Small Lymphocytic Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Splenic Marginal Zone Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Diffuse Mixed Cell Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Small Intestine Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Testicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Intraocular Lymphoma

Treatments: Biological: rituximab; Biological: oblimersen sodium; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: NIH

Identifiers

NCT00054639

N01CM17003 (U.S. NIH Grant/Contract)

N01CM17107 (U.S. NIH Grant/Contract)

N01CM62202 (U.S. NIH Grant/Contract)

NCI-2011-00617

ID02-148

N01CM62203 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Treatment (oblimersen sodium and monoclonal antibody therapy)

Experimental group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Biological: oblimersen sodium

Biological: rituximab