Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma
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
1 other identifier
interventional
22
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 9, 2002
CompletedFirst Posted
Study publicly available on registry
May 10, 2002
CompletedJune 24, 2005
October 1, 2004
May 9, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Favrillelead
Study Sites (12)
Scripps Stevens Cancer Center
La Jolla, California, 92037, United States
University of California San Diego
La Jolla, California, 92093, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048, United States
Oncology Associates of San Diego
San Diego, California, 92123, United States
Medical Group of North County
Vista, California, 92083, United States
University of Florida, Jacksonville
Jacksonville, Florida, 32209, United States
Northwestern University
Chicago, Illinois, 60611, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
New York Hospital - Cornell Medical Center
New York, New York, 10021, United States
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
The Bronx, New York, 10466, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45219, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 9, 2002
First Posted
May 10, 2002
Study Start
March 1, 2001
Last Updated
June 24, 2005
Record last verified: 2004-10