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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00251394

Collaborator

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

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2004

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Jul 1, 2009

Outcome Measures

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. [2 years]

Secondary Outcome Measures

To assess the overall response rate following treatment [2 years]
to determine duration of response and time to progression []
to further define the safety profile of 1018 ISS [2 years]
to explore the biologic activity of 1018 ISS. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115