Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma

Status unconfirmed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.

Key facts

Study ID: NCT00041730
Run by: Favrille
People needed: 90
Starts: 2002-07-01
Last updated by the study team: 2009-09-30

Who can join

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

You may qualify if…

18 years of age or older
Patients that are treatment naive OR
Relapsed or refractory following chemotherapy OR
Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease.
Tumor accessible for biopsy or previously existing recent biopsy material
Measurable disease after node biopsy
Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
Performance status (ECOG) of 0, 1 or 2
Absolute Granulocyte count > 1,000/mm3
Platelets > 100,000/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 are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory
More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens)
Treatment w/Fludarabine within 9 months of study entry
Patients with > 5,000 lymphocytes
Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype)
Concurrent immunosuppressive therapy (high-dose steroids; ect.)
Known history of CNS lymphoma or meningeal lymphomatosis
HIV positive
Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), 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 non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for >2 years
Treatment with an investigational drug within 8 weeks prior to study entry
Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.

Where it is running

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
University California, San Francisco — San Francisco, California, United States
University of Florida, Jacksonville — Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Northwestern University — Chicago, Illinois, United States
Ochsner Clinical Foundation — New Orleans, Louisiana, United States
Henry Ford Hospital — Detroit, Michigan, United States
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center — The Bronx, New York, United States
Oncology/Hematology Care Clinical Cancer Institute — Cincinnati, Ohio, United States
University Hospitals of Cleveland Case Western, Ireland Cancer Center — Cleveland, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
The Sarah Cannon Cancer Center — Nashville, Tennessee, United States
University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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