Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title: A Phase 2, Open-Label Study of the Efficacy, Safety, and Tolerability of Dynavax's Immunostimulatory Phosphorothiolate Oligodeoxyribonucleotide, 1018 ISS, Following Rituxan (Rituximab) Treatment in Patients With CD20+, B-Cell Follicular Non-Hodgkin's Lymphoma.

Status Completed

Clinical Trial Summary

The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells.

Clinical Trial Description

• Patients will receive four weekly infusions of Rituxan which is standard treatment for B-cell non-Hodgkin's lymphoma. Approximately 30 to 60 minutes after the second, third and fourth infusions of Rituxan, the patient will receive up to 3 injections of 1018 ISS under the skin. The number of injections will depend upon the patients weight. One week after the last Rituxan infusion the patient will receive a fourth and final injection of 1018 ISS.

• After completion of the 5-week treatment period, a physical examination and blood work will be performed. The patient will also be examined to see if the tumor has gotten smaller, bigger, or stayed the same size and in the same places by either CT scan or MRI. A bone marrow aspiration and biopsy will be done to examine any changes in bone marrow cells.

• The following tests will be performed to determine whether or not a patient is eligible to participate in this clinical study: Bone marrow aspiration and biopsy; lymph node biopsy; skin biopsy; standard x-ray tests (x-rays, CT scans, MRI, ultrasounds, and/or radioactive drug scans); and blood work.

• While receiving treatment patients will have the following procedures done; Physical examination once a week for 4 weeks, blood testing for any changes in the blood, blood chemistry and other blood components. Patients will also be requested to keep a diary between each study visit to record any health changes or any over-the-counter medication or herbal preparation they may have taken. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

• NCT number: NCT00251394
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Completion date: July 2009