An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.
The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall Survival
The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.
During treatment and every three months from end of treatment through end of study or approximately up to 5 years.
No
United States: Food and Drug Administration
CDX110-04
NCT01480479
November 2011
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Fletcher Allen Health Care | Burlington, Vermont 05401 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
North Shore University Hospital | Manhasset, New York 11030 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Rochester Medical Center | Rochester, New York 14642 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Temple University Hospital | Philadelphia, Pennsylvania 19140 |
University of California, San Francisco | San Francisco, California 94143 |
Atlanta Cancer Care | Atlanta, Georgia 30342 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Johns Hopkins University School of Medicine | Baltimore, Maryland 21205 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
University of Florida | Gainesville, Florida 32610-0277 |
Yale University | New Haven, Connecticut 06520 |
Ohio State University | Columbus, Ohio 43210 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University of Chicago | Chicago, Illinois 60637 |
USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
John Theurer Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Baylor Research Institute | Dallas, Texas 75246 |
Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Norton Cancer Institute | Louisville, Kentucky 40207 |
University of California, Davis | Sacramento, California 95818 |
University of Michigan Health System | Ann Arbor, Michigan |
Center for Cancer and Blood Disorders, PC | Bethesda, Maryland 20817 |
Swedish Neuroscience Institute | Seattle, Washington 98122 |
Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611-2941 |
LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport, Louisiana 71130 |
City of Hope Cancer Center | Duarte, California 91010 |
Georgia Health Sciences University | Augusta, Georgia 30912 |
Wake Forest Baptist Health | Winston-Salem, North Carolina 27157 |
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center | Durham, North Carolina 27710 |
University of Wisconsin Paul P Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792 |
UC San Diego Moores Cancer Center | La Jolla, California 92093 |
North Shore University Health System | Skokie, Illinois 60077 |
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85013 |
San Diego Pacific Oncology & Hematology Associates, Inc | Encinitas, California 92024 |
Stanford Cancer Institute, Stanford University | Stanford, California 94305 |
Mount Sinai Medical Center, Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Winship Cancer Institute, Emory University School of Medicine | Atlanta, Georgia 30322 |
Covenant Clinic / Iowa Spine and Brain Institute | Waterloo, Iowa 50702 |
Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center | Lansing, Michigan 48912 |
St. Mary's of Michigan Medical Center/Field Neurosciences Institute | Saginaw, Michigan 48604 |
New Jersey Neuroscience Institute, JFK Medical Center | Edison, New Jersey 08818 |
Christiana Care Health Services | Newark, New Jersey 19713 |
Dent Neurosciences Research Institute | Amherst, New York 14226 |
The Long Island Brain Tumor Center at Neurology Surgery, P.C. | Great Neck, New York 11021 |
Columbia University Medical Center - The Neurologic Institute of New York | New York, New York 10032 |
Brain and Spine Surgeons of New York | White Plains, New York 10604 |
University of Cincinnati Cancer Institute | Cincinnati, Ohio 45267 |
University Hospitals, Case Medical Center (Cleveland) | Cleveland, Ohio 44106 |
Providence Portland Medical Center, Oncology & Hematology Care | Portland, Oregon 97213 |
Pacific Neurosurgical | Portland, Oregon 97227 |
Lehigh Valley Physician Group-Hematology-Oncology Associates | Allentown, Pennsylvania 18103 |
West Penn. Allegheny Health System | Pittsburg, Pennsylvania 15212 |
Medical University of South Carolina - Department of Neuroscience | Charleston, South Carolina 29425 |
University of Tennessee Medical Center - Knoxville | Knoxville, Tennessee 37920 |
Texas Oncology Midtwon | Austin, Texas 78705 |
The Methodist Neurological Institute | Houston, Texas 77030 |
University of Utah Department of Neurosurgery | Salt Lake City, Utah 84112 |
University of Virginia Healthcare System | Charlottesville, Virginia 22908 |
University of Arizona Health Network | Tucson, Arizona 85724 |
Kaiser Permanente Hawaii Moanalua Medical Center | Honolulu, Hawaii 96819 |
Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute | Minneapolis, Minnesota 55407 |