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Spots Global Cancer Trial Database for A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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