Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00104819
- Lead Sponsor
- Favrille
- Brief Summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)â„¢ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavIdâ„¢ while enrolled on protocol FAV-ID-06.
Secondary
* Determine the response rate and duration of response in patients treated with this regimen.
* Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen.
* Determine the time to progression in patients treated with this regimen.
* Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm).
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression.
After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment.
PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 238
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)â„¢ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)â„¢ during participation on study Favld-06
- Secondary Outcome Measures
Name Time Method Response rate by modified Cheson Criteria Duration of response by modified Cheson Criteria Time to progression Response rate improvement
Trial Locations
- Locations (51)
Stanford Cancer Center
🇺🇸Stanford, California, United States
Rocky Mountain Cancer Centers - Denver Midtown
🇺🇸Denver, Colorado, United States
Helen F. Graham Cancer Center at Christiana Hospital
🇺🇸Newark, Delaware, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Sharp Memorial Hospital Cancer Center
🇺🇸San Diego, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Kootenai Cancer Center - Coeur d'Alene
🇺🇸Coeur d'Alene, Idaho, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Roger Maris Cancer Center at MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Sarah Cannon Cancer Center at Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Kaiser Permanente Medical Office - Interstate Medical Office Central
🇺🇸Portland, Oregon, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Cancer Care Centers of South Texas - Medical Center
🇺🇸San Antonio, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Center for Hematology-Oncology - Boca Raton
🇺🇸Boca Raton, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Greater Baltimore Medical Center Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Rush Cancer Institute at Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States