Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00089115
- Lead Sponsor
- Favrille
- Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells.
PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF) with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.
Secondary
* Compare response rate improvement in patients treated with these regimens.
* Compare overall complete response rate in patients treated with these regimens.
* Compare duration of response in patients treated with these regimens.
* Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior treatment (yes vs no) and response to rituximab during study (complete response \[CR\] or partial response \[PR\] vs stable disease \[SD\]).
All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of rituximab, patients are assessed for response. Patients with progressive disease are removed from the study and do not undergo randomization. Patients with a CR, PR, or SD are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
* Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days 1-4.
In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease. After the first 6 months, patients with a CR, PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for 1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease progression.
Patients are followed every 3 months for 2 years and then every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression after 248 patients have progressed
- Secondary Outcome Measures
Name Time Method Response rate improvement after 248 patients have progressed Overall complete response rate by modified Cheson Criteria after 248 patients have progressed Duration of response by modified Cheson Criteria after 248 patients have progressed Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed
Trial Locations
- Locations (60)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
University of Florida Health Science Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Fox Chase-Temple Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Sharp Memorial Hospital Cancer Center
🇺🇸San Diego, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Baylor University Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Center for Hematology-Oncology - Boca Raton
🇺🇸Boca Raton, Florida, United States
Sarah Cannon Cancer Center at Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Kaiser Permanente Medical Office - Interstate Medical Office Central
🇺🇸Portland, Oregon, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Beth Israel Medical Center - Philipps Ambulatory Care Center
🇺🇸New York, New York, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Cancer Care Network of South Texas
🇺🇸San Antonio, Texas, United States
Rocky Mountain Cancer Centers - Denver Midtown
🇺🇸Denver, Colorado, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center
🇺🇸Newark, Delaware, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States