Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
Public ClinicalTrials.gov record NCT01480479. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
Study identification
- NCT ID
- NCT01480479
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 745 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2011 (Type not available)
- Primary completion
- Nov 2016 (Actual)
- Completion
- Nov 2016 (Actual)
- Last update posted
- Jan 16, 2018
2011 – 2016
United States locations
- U.S. sites
- 88
- U.S. states
- 34
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | — |
| Barrow Neurological Institute at St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| University of Arizona Health Network | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| City of Hope Cancer Center | Duarte | California | 91010 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Kaiser Permanente, Redwood City Medical Center | Redwood City | California | 94063 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Stanford Cancer Institute, Stanford University | Stanford | California | 94305 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale University Medical Center | New Haven | Connecticut | 06520 | — |
| Christiana Care Health Services | Newark | Delaware | 19713 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Mount Sinai Medical Center, Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| MD Anderson Cancer Center Orlando | Orlando | Florida | 32806 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Atlanta Cancer Care | Atlanta | Georgia | 30005 | — |
| Winship Cancer Institute, Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Kaiser Permanente Hawaii Moanalua Medical Center | Honolulu | Hawaii | 96819 | — |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| North Shore University Health System | Evanston | Illinois | 60201 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Covenant Clinic / Iowa Spine and Brain Institute | Waterloo | Iowa | 50702 | — |
| University of Kentucky | Lexington | Kentucky | 40536-0093 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | — |
| LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport | Louisiana | 71103 | — |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21231 | — |
| Center for Cancer and Blood Disorders, PC | Bethesda | Maryland | 20817 | — |
| Dana-Farber Cancer Institute and Mass General Hospital Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| 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 | — |
| Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute | Minneapolis | Minnesota | 55407 | — |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| New Jersey Neuroscience Institute, JFK Medical Center | Edison | New Jersey | 08818 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Dent Neurosciences Research Institute | Amherst | New York | 14226 | — |
| New York Methodist Hospital | Brooklyn | New York | 11215 | — |
| The Long Island Brain Tumor Center at Neurology Surgery, P.C. | Great Neck | New York | 11021 | — |
| North Shore University Hospital | Manhasset | New York | 11030-3186 | — |
| Columbia University Medical Center - The Neurologic Institute of New York | New York | New York | 10032 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Brain and Spine Surgeons of New York | White Plains | New York | 10604 | — |
| The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45267 | — |
| University Hospitals, Case Medical Center (Cleveland) | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| 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 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| West Penn. Allegheny Health System | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina - Department of Neuroscience | Charleston | South Carolina | 29425 | — |
| University of Tennessee Medical Center - Knoxville | Knoxville | Tennessee | 37920 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology Midtwon | Austin | Texas | 78705 | — |
| Baylor Research Institute | Dallas | Texas | 75246 | — |
| The Methodist Neurological Institute | Houston | Texas | 77030 | — |
| University of Utah Department of Neurosurgery | Salt Lake City | Utah | 84112 | — |
| Fletcher Allen Health Care | Burlington | Vermont | 05405 | — |
| University of Virginia Healthcare System | Charlottesville | Virginia | 22908 | — |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| University of Wisconsin Paul P Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 135 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01480479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 16, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01480479 live on ClinicalTrials.gov.