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Brief Title: A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
Official Title: A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
Study ID: NCT01498328
Brief Summary: 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 drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.
Detailed Description: This Phase II study will enroll patients into three groups. Group 1 are patients who have never been treated with bevacizumab. These patients will be randomly assigned to receive either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or within 2 months of discontinuing bevacizumab). These patients will all receive rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease progression or intolerance and all patients will be followed for survival. Patients may be treated with other therapies that are not part of the study after discontinuing treatment with the study vaccine.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center / Barrow Neurological Institute, Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
University of Southern California (USC) Norris Comprehensive Cancer Center, Los Angeles, California, United States
UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California San Francisco, San Francisco, California, United States
Stanford Cancer Institute, Stanford University, Stanford, California, United States
University of Colorado, Denver, Aurora, Colorado, United States
Memorial Cancer Institute, Hollywood, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
Piedmont Atlanta Hospital, Atlanta, Georgia, United States
Atlanta Cancer Care, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
NorthShore University Health System, Evanston, Illinois, United States
The Johns Hopkins Hospital, Baltimore, Maryland, United States
Dana-Farber Cancer Institute and Mass General Hospital, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Sparrow Cancer Center, Lansing, Michigan, United States
John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
New Jersey Neuroscience Institute JFK Medical Center, Edison, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Dent Neurologic Institute, 3980 Sheridan Dr, 3rd Flr Clinical Rsch, Amherst, New York, United States
The Long Island Brain Tumor Center at Neurology Surgery, P.C., Commack, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Hospital, Stony Brook, New York, United States
The Preston Robert Tisch Brain Tumor Center; Duke University Medical Center, Durham, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Legacy Research Institute, Portland, Oregon, United States
Lehigh Valley Hospital-John and Dorothy Morgan Cancer Center, Allentown, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology Midtown, Austin, Texas, United States
Baylor Research Institute, Dallas, Texas, United States
UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Swedish Neuroscience Research, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States