Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas
The purpose of this study was to assess the ability of active immunotherapy to induce tumor
regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen,
the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic
sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the
clonal expansion of a single B-cell and all tumor cells express that 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. While initial studies reported a predominately humoral
(antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor
immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
FavId-01
NCT00036426
March 2001
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Henry Ford Hospital | Detroit, Michigan 48202 |
University of California San Diego | La Jolla, California 92093 |
Tower Hematology Oncology Medical Group | Los Angeles, California 90048 |
Northwestern University | Chicago, Illinois 60611 |
Scripps Stevens Cancer Center | La Jolla, California 92037 |
Oncology Associates of San Diego | San Diego, California 92123 |
Medical Group of North County | Vista, California 92083 |
University of Florida, Jacksonville | Jacksonville, Florida 32209 |
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center | Bronx, New York 10466 |
New York Hospital - Cornell Medical Center | New York, New York 10021 |
Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |