A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone
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, Outcomes Assessor), Primary Purpose: Treatment
The proportion of patients in each treatment group who are Responders at Week 2 and continue at Week 5
Prospective
Yes
William Shapiro, MD
Principal Investigator
Barrow Neurological Institute
United States: Food and Drug Administration
NTI 0303
NCT00088166
May 2004
March 2008
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Stanford University Medical Center | Stanford, California 94305-5408 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
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 |
Mayo Clinic | Jacksonville, Florida 32224 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
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 |
UCSF Fresno Center for Clinical Studies | Fresno, California 93702 |
UC Davis Medical Center, Division of Medical Oncology | Sacramento, California 95817 |
UC San Diego, Thornton Hospital | San Diego, California 92037 |
Colorado Neurological Institute | Englewood, Colorado 80113 |
Cancer Institute of Orlando | Orlando, Florida 32804 |
Moffitt Cancer Center & Research Institute | Tampa, Florida 33612-9497 |
Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
Hermelin Brain Tumor Center, Henry Ford Hospital | Detroit, Michigan 48202 |
Neurology Group of Bergen County | Ridgewood, New Jersey 07450 |
University Hematology Oncology Care, LLC | Cincinnati, Ohio 43210 |
Oregon Clinic | Portland, Oregon 97210 |
Virginia Mason Clinic | Seattle, Washington 98111 |