The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
2mg/day
Barrow Neurological Institute
Phoenix, Arizona, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford University Medical Center
Palo Alto, California, United States
UC Davis Medical Center, Division of Medical Oncology
Sacramento, California, United States
UC San Diego Cancer Center
San Diego, California, United States
Long Term Safety and Tolerability of hCRF
Number of patients reporting adverse events
Time frame: Prospective
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University of Colorado Cancer Center
Aurora, Colorado, United States
Colorado Neurological Institute Center for Brain & Spinal Tumors
Englewood, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Cancer Institute of Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
...and 22 more locations