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

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
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00251394

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

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
Estimated Study Completion Date:	July 2009
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously once weekly for four weeks.

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

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:	Dana-Farber Cancer Institute ( Arnold Freedman, MD )
Study ID Numbers:	03-411, R21, U10402
Study First Received:	November 8, 2005
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00251394 History of Changes
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 +

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Follicular

Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Follicular Lymphoma
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lymphoma, Follicular

Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on July 06, 2009