Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus
FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their
idiotype. Secondary objectives are the determination of overall objective response rate,
duration of response and time to progression. B-cell malignancies express a unique antigen,
the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic
sequence used in production of unique Id protein. No normal B-cells possess that Id on their
cell surface. Hence, Id protein should serve as an ideal target for individualized active
immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak
immunogens. To augment the immune response against Id, the Id protein must be chemically
coupled to a strongly immunogenic protein. keyhole limpet hemocyanin (KLH) is a commonly
used protein carrier capable of augmenting the body's immune reaction against Id protein.
For vaccines which produce primarily an antibody response, there is a concern that combining
immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months
post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would
blunt any antibody response. For vaccines that induce strong T-cell responses like Id-KLH
plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually
increase the T-cell response to the vaccine. GM-CSF is a hematopoietic growth factor that
stimulates T-cell proliferation. T-cell response to both the patient's Idiotype and KLH
will be measured during this trial.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
FavId-04
NCT00041730
July 2002
Name | Location |
---|---|
Henry Ford Hospital | Detroit, Michigan 48202 |
Tower Hematology Oncology Medical Group | Los Angeles, California 90048 |
University of Virginia | Charlottesville, Virginia 22908 |
Northwestern University | Chicago, Illinois 60611 |
The Ohio State University | Columbus, Ohio 43210 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
The Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
Oncology Associates of San Diego | San Diego, California 92123 |
University of Florida, Jacksonville | Jacksonville, Florida 32209 |
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center | Bronx, New York 10466 |
University of California, San Diego | La Jolla, California 92037-1709 |
University California, San Francisco | San Francisco, California 94143 |
Ochsner Clinical Foundation | New Orleans, Louisiana 70121 |
Oncology/Hematology Care Clinical Cancer Institute | Cincinnati, Ohio 45219 |
University Hospitals of Cleveland Case Western, Ireland Cancer Center | Cleveland, Ohio 44106 |