Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
Completed · Phase 3
Conditions studied: Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component
In brief
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.
Key facts
- Study ID
- NCT01480479
- Run by
- Celldex Therapeutics
- People needed
- 745
- Starts
- 2011-11-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2018-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
- Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
- University of Arizona Health Network — Tucson, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- City of Hope Cancer Center — Duarte, California, United States
- UC San Diego Moores Cancer Center — La Jolla, California, United States
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Chao Family Comprehensive Cancer Center — Orange, California, United States
- Kaiser Permanente, Redwood City Medical Center — Redwood City, California, United States
- University of California, Davis — Sacramento, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Stanford Cancer Institute, Stanford University — Stanford, California, United States
- Hartford Hospital — Hartford, Connecticut, United States
- Yale University Medical Center — New Haven, Connecticut, United States
- Christiana Care Health Services — Newark, Delaware, United States
- University of Florida — Gainesville, Florida, United States
- Mount Sinai Medical Center, Comprehensive Cancer Center — Miami Beach, Florida, United States
- MD Anderson Cancer Center Orlando — Orlando, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Atlanta Cancer Care — Atlanta, Georgia, United States
- Winship Cancer Institute, Emory University School of Medicine — Atlanta, Georgia, United States
- Georgia Regents University — Augusta, Georgia, United States
- Kaiser Permanente Hawaii Moanalua Medical Center — Honolulu, Hawaii, United States
- Northwestern University Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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