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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251394
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : January 29, 2010
Dynavax Technologies Corporation
James P. Wilmot Cancer Center
University of Rochester
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Rituxan Drug: 1018 ISS Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the overall response rate following treatment [ Time Frame: 2 years ]
  2. to determine duration of response and time to progression
  3. to further define the safety profile of 1018 ISS [ Time Frame: 2 years ]
  4. to explore the biologic activity of 1018 ISS. [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251394

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Dynavax Technologies Corporation
James P. Wilmot Cancer Center
University of Rochester
Brigham and Women's Hospital
Massachusetts General Hospital
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Principal Investigator: Arnold Freedman, MD Dana-Farber Cancer Institute
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Responsible Party: Arnold Freedman, MD, Dana-Farber Cancer Institute Identifier: NCT00251394    
Other Study ID Numbers: 03-411
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: July 2009
Keywords provided by Dana-Farber Cancer Institute:
B-Cell follicular non-Hodgkin's lymphoma
1018 ISS
CD 20 +
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents