XERECEPTÂ® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
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 compare the safety and efficacy of XERECEPT® to dexamethasone
(Decadron) a common treatment for symptoms of brain swelling (edema). This study is
specifically aimed at patients who require chronic high doses of dexamethasone to manage
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The proportion of patients in each treatment group who are Responders at Week 2 and continue at Week 5
Percent of patients in each treatment group achieving 50% reduction in
dexamethasone usage relative to Baseline by Week 2 without deterioration
in neurological function as measured by the 10-Item Neurological
Exam and the KPS
The proportion of patients in each treatment group who are Responders at
Week 2 and who continue to be Responders at Weeks 5 and 8
Change from Baseline in the 10-Item Neurological Examination Score at
Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week
Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5,
8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up
Change from Baseline in the Signal Symptom Score at Weeks 2, 5, 8, 12
(or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up visit)
Change from Baseline in the FACT-Br quality of life results at Weeks 5, 12
(or Early Study Drug Discontinuation), and 16
Change from Baseline in Myopathy assessment results at Week 12 (or
Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up
Maximum percent reduction in dexamethasone usage relative to Baseline
achieved during the study
Time to discontinuation of blinded study medication prior to the end of
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 brain tumor or, if
metastatic, documentation and histology (if available) of primary source of cancer.
- Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline.
- Patient has required administration of dexamethasone to control symptoms of
peritumoral edema for at least 30 days.
- Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline.
- Need for administration of dexamethasone to treat peritumoral brain edema (referenced
above) has been documented by MRI or comparable diagnostic technology within 21 days
- Karnofsky score of > 50 at Screening and Baseline.
- Capable of self-administration of subcutaneous injections twice daily for 12 weeks, 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 Screening.
- Must be 18 years of age or older
- Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the
introduction of new chemotherapeutic regime within the first 5 weeks of study
enrollment. Treatment with pre-study chemotherapy may continue.
- Concurrent enrollment in any other investigational drug or device study, or plan to
enroll in such a study during the first 5 weeks of treatment.
- Systemic steroid use for any indication other than peritumoral brain edema.
- Use or intended use of dexamethasone as an anti-emetic during Screening or Study
- Non-compliance with dexamethasone or anticonvulsant therapy.
- 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 for study
- 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 infection.
- Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for
women of childbearing potential.
- Any conditions that are considered contraindications for patients to receive niacin,
e. g. liver disease (with LFTs > 3 times the upper limit of the norm),active peptic
ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.
Locations and Contacts
Cross Cancer Institute, Edmonton, Alberta T6G1ZT, Canada
Barrow Neurological Institute, Phoenix, Arizona 85013, United States
UC San Diego, Thornton Hospital, San Diego, California 92037, United States
UC Davis Medical Center, Division of Medical Oncology, Sacramento, California 95817, United States
Stanford University Medical Center, Palo Alto, California 94305, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States
UCSF Fresno Center for Clinical Studies, Fresno, California 93702, United States
Colorado Neurological Institute, Englewood, Colorado 80113, United States
University of Colorado Cancer Center, Aurora, Colorado 80045, United States
Cancer Institute of Orlando, Orlando, Florida 32804, United States
Mayo Clinic, Jacksonville, Florida 32224, United States
Moffitt Cancer Center & Research Institute, Tampa, Florida 33612-9497, 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
CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, Michigan 48202, United States
The Moncton Hospital, Moncton, New Brunswick E1C 6Z8, Canada
Neurology Group of Bergen County, Ridgewood, New Jersey 07450, United States
Memorial Sloan Kettering Cancer Center, New York, New York 10021, United States
Dent Neurologic Institute, Amherst, New York 14226, United States
Weill Medical College of Cornell University, New York, New York 10021, United States
Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia B3H 1V7, Canada
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
Kingston General Hospital, Kingston, Ontario K7L 5P9, Canada
Sunnybrook and Women's College Health, Toronto, Ontario M4N 3M5, Canada
Oregon Clinic, Portland, Oregon 97210, United States
Virginia Mason Clinic, Seattle, Washington 98111, United States
University of Wisconsin, Madison, Wisconsin 53792, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3596, United States
Starting date: May 2004
Ending date: March 2008
Last updated: March 7, 2008