XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
Information source: Celtic Pharma Development Services
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Edema; Brain Tumor
Intervention: hCRF (Drug); placebo hCRF (Drug)
Phase: Phase 3
Sponsored by: Celtic Pharma Development Services
Official(s) and/or principal investigator(s):
William Shapiro, MD, Principal Investigator, Affiliation: Barrow Neurological Institute
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
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with
tumors and as a result, decrease neurological symptoms.
Minimum age: 18 Years.
Maximum age: N/A.
- Histologically confirmed diagnosis of a primary malignant glioma.
- Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone
- 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
- 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
- Central nervous system (CNS) infection.
- Conditions that are considered contradictions for patients to receive niacin
Locations and Contacts
Cross Cancer Institute, Edmonton, Alberta T6G1ZT, Canada
Barrow Neurological Institute, Phoenix, Arizona 85013, United States
UC San Diego Cancer Center, La Jolla, California 92093, United States
Stanford University Medical Center, Palo Alto, California 94305, United States
UC Davis Medical Center, Sacramento, California 95817, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States
University of Colorado Cancer Center, Aurora, Colorado 80045, United States
Moffitt Cancer Center and Research, Tampa, Florida 33612, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia 30322, United States
Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611, United States
Evanston Northwestern Healthcare, Evanston, Illinois 60201, United States
Beth Israel Deaconess Med Center, Boston, Massachusetts 02215, United States
Field Neurosciences Institute, Saginaw, Michigan 48604, United States
Neurology Group of Bergen County, Ridgewood, New Jersey 07450, United States
Dent Neurologic Institute, Amherst, New York 14226, United States
Weill Medical College of Cornell University, New York, New York 10021, United States
Wake Forest University, Winston-Salem, North Carolina 27106, United States
The Ohio State University, Columbus, Ohio 43210, United States
University Hematology Oncology Care, LLC, Cincinnati, Ohio 43210, United States
Good Samaritan Hospital, Cincinnati, Ohio 45220, United States
Ottawa Regional Cancer Centre, Ottawa, Ontario K1H 1C4, Canada
Oregon Clinic, Portland, Oregon 97210, United States
Methodist Healthcare - University Hospital, Memphis, Tennessee 38103, United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
University of Wisconsin, Madison, Wisconsin 53792, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3596, United States
Starting date: January 2006
Ending date: January 2008
Last updated: December 27, 2007