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| Sponsor: | Favrille |
|---|---|
| Information provided by: | Favrille |
| ClinicalTrials.gov Identifier: | NCT00036426 |
Purpose
The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Low-Grade |
Biological: FavId (Id-KLH) active immunotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 22 |
| Study Start Date: | March 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, California | |
| University of California San Diego | |
| La Jolla, California, United States, 92093 | |
| Scripps Stevens Cancer Center | |
| La Jolla, California, United States, 92037 | |
| Tower Hematology Oncology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| Oncology Associates of San Diego | |
| San Diego, California, United States, 92123 | |
| Medical Group of North County | |
| Vista, California, United States, 92083 | |
| United States, Florida | |
| University of Florida, Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| 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 | |
| New York Hospital - Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Oncology Hematology Care, Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00036426 History of Changes |
| Obsolete Identifiers: | NCT00014157 |
| Other Study ID Numbers: | FavId-01 |
| Study First Received: | May 9, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
lymphoma vaccine idiotype KLH GM-CSF |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Immunoglobulin Idiotypes Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |