Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma
Lymphoma, Low-Grade
About this trial
This is an interventional treatment trial for Lymphoma, Low-Grade focused on measuring lymphoma, vaccine, idiotype, KLH, GM-CSF
Eligibility Criteria
Inclusion Criteria 18 years of age Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification) Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease. Tumor accessible for biopsy or previously existing biopsy material At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension Performance status (ECOG) of 0, 1 or 2 Absolute Granulocyte count ? 1,000/mm3 Total Bilirubin < 2 mg/dL AST and ALT < 2x Upper Limit of Normal Creatinine < 1.5 mg/dL Exclusion Criteria Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens Prior fludarabine Prior tumor-specific idiotype immunotherapy Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment Concurrent immunosuppressive therapy (high-dose steroids; etc) Prior splenectomy Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination Known history of CNS lymphoma or meningeal lymphomatosis HIV positive Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for > 2 years Treatment with an investigational drug within 30 days prior to study entry Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.
Sites / Locations
- Scripps Stevens Cancer Center
- University of California San Diego
- Tower Hematology Oncology Medical Group
- Oncology Associates of San Diego
- Medical Group of North County
- University of Florida, Jacksonville
- Northwestern University
- Henry Ford Hospital
- New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
- New York Hospital - Cornell Medical Center
- Oncology Hematology Care, Inc.
- Fox Chase Cancer Center