A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma
XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with
tumors and as a result, decrease neurological symptoms.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2.
Prospective
Yes
William Shapiro, MD
Principal Investigator
Barrow Neurological Institute
United States: Food and Drug Administration
NTI 0302
NCT00226668
January 2006
January 2008
Name | Location |
---|---|
Wake Forest University | Winston-Salem, North Carolina 27103 |
Stanford University Medical Center | Stanford, California 94305-5408 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Weill Medical College of Cornell University | New York, New York 10021 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Evanston Northwestern Healthcare | Evanston, Illinois 60201 |
The Ohio State University | Columbus, Ohio 43210 |
Barrow Neurological Institute | Phoenix, Arizona 85013 |
Northwestern University, Feinberg School of Medicine | Chicago, Illinois 60611 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Dent Neurologic Institute | Amherst, New York 14226 |
Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
Neurology Group of Bergen County | Ridgewood, New Jersey 07450 |
University Hematology Oncology Care, LLC | Cincinnati, Ohio 43210 |
Oregon Clinic | Portland, Oregon 97210 |
UC Davis Medical Center | Sacramento, California 95817 |
UC San Diego Cancer Center | San Diego, California 92037 |
Moffitt Cancer Center and Research | Tampa, Florida 33612 |
Beth Israel Deaconess Med Center | Boston, Massachusetts 02215 |
Field Neurosciences Institute | Saginaw, Michigan 48604 |
Methodist Healthcare - University Hospital | Memphis, Tennessee 38103 |