A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
This Phase II study will enroll patients into two 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 patients are those who are refractory to bevacizumab
(experienced recurrence or progression of glioblastoma while on 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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression-free survival rate
Evaluate the antitumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the progression-free survival rate at 6 months post-Day 1 (PFS 6).
6 months post-Day 1
No
United States: Food and Drug Administration
CDX110-06
NCT01498328
December 2011
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Rochester Medical Center | Rochester, New York 14642 |
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Atlanta Cancer Care | Atlanta, Georgia 30342 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
University of Florida | Gainesville, Florida 32610-0277 |
University of Chicago | Chicago, Illinois 60637 |
Baylor Research Institute | Dallas, Texas 75246 |
Utah Cancer Specialists | Salt Lake City, Utah 84106 |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
Sparrow Cancer Center | Lansing, Michigan 48912 |
University of Colorado, Denver | Aurora, Colorado 80045 |
NorthShore University health system | Evanston, Illinois 60201 |
Wake Forest Baptist Health | Winston-Salem, North Carolina 27157 |
Stanford Cancer Institute, Stanford University | Stanford, California 94305 |
The Long Island Brain Tumor Center at Neurology Surgery, P.C. | Great Neck, New York 11021 |
University of Cincinnati Cancer Institute | Cincinnati, Ohio 45267 |
St. Joseph's Hospital and Medical Center / Barrow Neurological Institute | Phoenix, Arizona 85013 |
University of Southern California (USC) Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
S. Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
The Preston Robert Tisch Brain Tumor Center; Duke University Medical Center | Durham, North Carolina 27710 |
Texas Oncology Midtown | Austin, Texas 78705 |
UC Irvine Chao Family Comprehensive Cancer Center | Orange, California 92868 |
Legacy Research Institute | Portland, Oregon 97232 |