XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
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
2 other identifiers
interventional
200
2 countries
34
Brief Summary
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 symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2004
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 20, 2004
CompletedFirst Posted
Study publicly available on registry
July 22, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
August 13, 2014
CompletedAugust 13, 2014
July 1, 2014
3.8 years
July 20, 2004
October 13, 2011
July 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5
The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following: * 50% or greater reduction in dexamethasone dose relative to Baseline * Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline * Karnofsky Score unchanged or increased relative to Baseline
Prospective
Secondary Outcomes (8)
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
Prospective
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
Prospective
Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)
Prospective
Change From Baseline in the Karnofsky Performance Score
Prospective
Change From Baseline in the FACT-Br Quality of Life Results
Prospective
- +3 more secondary outcomes
Study Arms (2)
I
EXPERIMENTALPatients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
II
PLACEBO COMPARATORPatient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
Interventions
hCRF ; open-label dexamethasone that the patient is currently taking
placebo hCRF 2mg/day and open-label dexamethasone that they are taking
Eligibility Criteria
You may qualify if:
- 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 of Baseline.
- 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
You may not qualify if:
- 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 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celtic Pharma Development Serviceslead
- Neurobiological Technologiescollaborator
Study Sites (34)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
UCSF Fresno Center for Clinical Studies
Fresno, California, 93702, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
UC Davis Medical Center, Division of Medical Oncology
Sacramento, California, 95817, United States
UC San Diego, Thornton Hospital
San Diego, California, 92037, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Cancer Institute of Orlando
Orlando, Florida, 32804, 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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Hermelin Brain Tumor Center, Henry Ford Hospital
Detroit, Michigan, 48202, United States
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
University Hematology Oncology Care, LLC
Cincinnati, Ohio, 43210, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
The Ohio State University
Columbus, Ohio, 43210, United States
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
Cross Cancer Institute
Edmonton, Alberta, T6G1ZT, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V7, Canada
Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Sunnybrook and Women's College Health
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Recht L, Mechtler LL, Wong ET, O'Connor PC, Rodda BE. Steroid-sparing effect of corticorelin acetate in peritumoral cerebral edema is associated with improvement in steroid-induced myopathy. J Clin Oncol. 2013 Mar 20;31(9):1182-7. doi: 10.1200/JCO.2012.43.9455. Epub 2013 Feb 4.
PMID: 23382470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Patrick O'Connor, MD, Managing Director Clinical Development
- Organization
- Celtic Pharma Development Services America Inc
Study Officials
- PRINCIPAL INVESTIGATOR
William Shapiro, MD
Barrow Neurological Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2004
First Posted
July 22, 2004
Study Start
May 1, 2004
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
August 13, 2014
Results First Posted
August 13, 2014
Record last verified: 2014-07