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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary:

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.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Number of Patients With Objective Response [ Time Frame: 2 months following study treatment ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: February 5, 2003
Date Started: January 2003
Date Completion:
Last Updated: May 13, 2014
Last Verified: March 2013