Status:
COMPLETED
Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Dynavax Technologies Corporation
James P. Wilmot Cancer Center
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 R...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00251394
Start Date
July 1 2004
End Date
July 1 2009
Last Update
January 29 2010
Active Locations (3)
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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