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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00251394
First received: November 8, 2005
Last updated: January 28, 2010
Last verified: July 2009
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Rituxan
Drug: 1018 ISS
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the overall response rate following treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • to determine duration of response and time to progression [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to further define the safety profile of 1018 ISS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • to explore the biologic activity of 1018 ISS. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2004
Study Completion Date: July 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251394

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Investigators
Principal Investigator: Arnold Freedman, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Arnold Freedman, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00251394     History of Changes
Other Study ID Numbers: 03-411, R21, U10402
Study First Received: November 8, 2005
Last Updated: January 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
B-Cell follicular non-Hodgkin's lymphoma
Rituxan
Rituximab
1018 ISS
CD 20 +

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014