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.
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
Arnold Freedman, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|