Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma

Status unconfirmed · Phase 2

Conditions studied: Lymphoma, Low-Grade

In brief

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.

Key facts

Study ID

NCT00036426

Run by

Favrille

People needed

22

Starts

2001-03-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Scripps Stevens Cancer Center — La Jolla, California, United States
• University of California San Diego — La Jolla, California, United States
• Tower Hematology Oncology Medical Group — Los Angeles, California, United States
• Oncology Associates of San Diego — San Diego, California, United States
• Medical Group of North County — Vista, California, United States
• University of Florida, Jacksonville — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• New York Hospital - Cornell Medical Center — New York, New York, United States
• New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center — The Bronx, New York, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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