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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Dynavax Technologies Corporation; James P. Wilmot Cancer Center; Massachusetts General Hospital; University of Rochester
• Treatments: Rituximab

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