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Sponsored by: |
Favrille |
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Information provided by: | Favrille |
ClinicalTrials.gov Identifier: | NCT00041730 |
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.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma |
Biological: Id-KLH |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 90 |
Study Start Date: | July 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, California | |
Oncology Associates of San Diego | |
San Diego, California, United States, 92123 | |
Tower Hematology Oncology Medical Group | |
Los Angeles, California, United States, 90048 | |
University of California, San Diego | |
La Jolla, California, United States, 92093 | |
University California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Florida | |
University of Florida, Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Louisiana | |
Ochsner Clinical Foundation | |
New Orleans, Louisiana, United States, 70121 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center | |
Bronx, New York, United States, 10466 | |
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
Oncology/Hematology Care Clinical Cancer Institute | |
Cincinnati, Ohio, United States, 45219 | |
University Hospitals of Cleveland Case Western, Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Tennessee | |
The Sarah Cannon Cancer Center | |
Nashville, Tennessee, United States, 37203 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22902 |
Study ID Numbers: | FavId-04 |
Study First Received: | July 15, 2002 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00041730 History of Changes |
Health Authority: | United States: Food and Drug Administration |
lymphoma vaccine idiotype |
KLH GM-CSF FavId |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders Immunoglobulin Idiotypes |
B-cell Lymphomas Rituximab Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |