Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Time to progression after 248 patients have progressed
No
John F. Bender, PharmD
Study Chair
Favrille
United States: Federal Government
CDR0000378046
NCT00089115
July 2004
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
North Shore University Hospital | Manhasset, New York 11030 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Mid Dakota Clinic, P. C. | Bismarck, North Dakota 58501 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Sarah Cannon Cancer Center at Centennial Medical Center | Nashville, Tennessee 37203 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York 10003 |
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian | Newport Beach, California 92663 |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
Rocky Mountain Cancer Centers - Denver Midtown | Denver, Colorado 80218 |
Baylor University Medical Center - Dallas | Dallas, Texas 75246 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
Sharp Memorial Hospital Cancer Center | San Diego, California 92123 |
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center | Newark, Delaware 19713-2055 |
Center for Hematology-Oncology - Boca Raton | Boca Raton, Florida 33486 |
New Mexico Cancer Center | Albuquerque, New Mexico 87109 |
Kaiser Permanente Medical Office - Interstate Medical Office Central | Portland, Oregon 97227 |
Cancer Care Network of South Texas | San Antonio, Texas 78229 |