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

NCT00251394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-01-29

No results posted yet for this study

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.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Rituxan

Given intravenously once weekly for four weeks.

DRUG

1018 ISS

Given as an injection under the skin after the 2nd, 3rd and 4th rituxan infusion. One week after the last rituxan infusion is given, a fourth and final 1018ISS injection will be given.

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    collaborator INDUSTRY

  • James P. Wilmot Cancer Center

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Arnold Freedman, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-12-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251394 on ClinicalTrials.gov