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

January 28, 2010 updated by: Dana-Farber Cancer Institute

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Pathological evidence of CD20+, B-cell follicular non-Hodgkin's lymphoma
  • Received at least one previous chemotherapy regimen for lymphoma
  • Hemoglobin > 8.5 g/dl
  • WBC > 2,000/mm3
  • ANC > 1,000/mm3
  • Platelet count > 75,000/mm3
  • ECOG performance status of less than or equal to 2
  • Life expectancy of greater than 4 months
  • Women and men of childbearing potential must be willing to use highly effective methods of birth control for duration of time on the study

Exclusion Criteria:

  • Pregnant of lactating women
  • Treatment with chemotherapy, including systemic steroids, or radiation therapy within 30 days
  • Current use of systemic or inhaled steroids
  • Treatment with radioimmunotherapy, autologous stem cell transplantation, or fludarabine within 6 months
  • Disease progression within 6 months of any previous rituximab therapy
  • History of allogenic transplantation, including nonmyeloablative transplantation
  • Unstable angina, symptomatic cardiac arrhythmia or clinical heart failure
  • Severe pulmonary disease, symptomatic pleural effusions, or clinically significant pulmonary symptoms
  • Active infection requiring systemic antibiotic, antiviral, or antifungal therapy
  • Clinically apparent CNS lymphoma
  • Major surgery within 2 weeks
  • Known human anti-murine antibody (HAMA) or human anti-chimeric antibody (HACA) response
  • Known Hepatitis B surface antigen positive
  • History of autoimmune disorder
  • Current therapeutic use of anticoagulants
  • History of coagulopathy
  • Known allergy to any of the components of 1018 ISS or Rituxan
  • Participation in another investigational trial within 30 days
  • Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the overall response rate following treatment
Time Frame: 2 years
2 years
to determine duration of response and time to progression
to further define the safety profile of 1018 ISS
Time Frame: 2 years
2 years
to explore the biologic activity of 1018 ISS.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Brigham and Women's Hospital
University of Rochester
Dynavax Technologies Corporation
James P. Wilmot Cancer Center

Investigators

  • Principal Investigator: Arnold Freedman, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (ESTIMATE)

November 10, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-411
  • R21
  • U10402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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