PATIENTS WITH STABLE OR PROGRESSIVE GRADE 1 OR 2 FOLLICULAR B-CELL LYMPHOMAS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label, single-arm Phase II study designed to evaluate the clinical efficacy of immunotherapy with tumor-specific idiotype protein coupled to KLH (FavId) in combination with soluble GM-CSF immunoadjuvant in this patient with stable grade 1 or 2 follicular B-cell lymphoma (WHO classification). The patient will be followed for objective response, time to progression, immune response and safety. The patient who will participate in this single compassionate use study underwent an involved lymphnode biopsy to obtain tissue for morphological classification, immunophenotypic characterization and to provide material for generation of tumor specific Id protein. The patient's history is as follows: A 53-year-old woman initially diagnosed with advanced follicular Lymphoma in 1998. Her treatment history as follows: 1998 Eight cycles of rituximab, followed by observation. April 2000 Recurrent disease, treated with 4 cycles of rituximab. February 2001 Enrolled in FavId-01 trial, received 6 cycles weekly rituximab. May 2001 Inadequate response to rituximab, withdrew from FavId-01 vaccine trial. June 2001 Received PEP-C for 3 months with stable disease followed by chlorambucil for 3 months. April 2002 Developed progressive disease and was treated with seven cycles fludarabine and mitoxantrone with partial response. April 2003 Treated with 4 cycles CHOP with minimal response, received gemcitabine, navelbine, and Doxil with minimal response. April 2004 Treated with fludarabine and rituximab with partial response. Treatment stopped for low blood counts. October 2004 Treated with 8 cycles of weekly rituximab. June 2005 Non-myeloblative matched unrelated donor hematopoietic stem cell transplant. September 2005 PET/CT, no evidence of lymphoma on bone marrow. This patient has follicular B-cell lymphoma, and would be treated using the same dose, schedule and monitoring as outlined in protocol FavId-01. The patient has asked to receive the vaccine that was manufactured for the FavId-01 trial at Stanford. A request for permission to cross-file a Single Patient IND for Compassionate Use to Favrille's IND for FavId, BB-IND-8786 was submitted to the FDA and approval was granted. The protocol was approved by the Stanford IRB.