An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
- Conditions
- Brain EdemaBrain Tumor
- Interventions
- Registration Number
- NCT00226655
- Lead Sponsor
- Celtic Pharma Development Services
- Brief Summary
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.
- Detailed Description
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
- Have a Karnofsky Performance of > 50 at Baseline
- Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
- Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
- For women of childbearing potential: a negative serum pregnancy test at Baseline
- Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
- Systemic steroid use for any indication other than peritumoral brain edema.
- Use or intended use of dexamethasone as an anti-emetic during study.
- Clinical signs and symptoms of cerebral herniation.
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation.
- Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
- Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
- Central nervous system (CNS) infection.
- Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I hCRF [XERECEPT (corticorelin acetate injection)] All patients will receive hCRF (XERECEPT) 2mg/day
- Primary Outcome Measures
Name Time Method Long Term Safety and Tolerability of hCRF Prospective Number of patients reporting adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Caner Centre of Southwestern Ontario/ Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Ottawa Regional Cancer Center
🇨🇦Ottawa, Ontario, Canada
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Oregon Clinic
🇺🇸Portland, Oregon, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Colorado Neurological Institute Center for Brain & Spinal Tumors
🇺🇸Englewood, Colorado, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, 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
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Cancer Institute of Orlando
🇺🇸Orlando, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Feinberg School of Medicine, Northwestern University
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Hermelin Brain Tumor Center, Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University Hematology Oncology Care, LLC
🇺🇸Cincinnati, Ohio, United States
Virginia Mason Clinic
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Sunnybrook and Women's College Health Sciences Center
🇨🇦Toronto, Ontario, Canada