XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
- Registration Number
- NCT00226668
- Lead Sponsor
- Celtic Pharma Development Services
- Brief Summary
The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.
- 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
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 120
- Histologically confirmed diagnosis of a primary malignant glioma.
- Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
- If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
- Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
- Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
- Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
- Systemic steroid use for any other indication than peritumoral brain edema.
- Patients on dexamethasone or anticonvulsant therapy.
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
- Central nervous system (CNS) infection.
- Conditions that are considered contradictions for patients to receive niacin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I hCRF Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking II placebo hCRF Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
UC San Diego Cancer Center
🇺🇸La Jolla, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Field Neurosciences Institute
🇺🇸Saginaw, Michigan, United States
Methodist Healthcare - University Hospital
🇺🇸Memphis, Tennessee, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center and Research
🇺🇸Tampa, Florida, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University, Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Beth Israel Deaconess Med Center
🇺🇸Boston, Massachusetts, United States
Neurology Group of Bergen County
🇺🇸Ridgewood, New Jersey, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University Hematology Oncology Care, LLC
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Oregon Clinic
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States