Back to resultsXERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
Primary Purpose
Brain Edema, Brain Tumor
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
hCRF
placebo hCRF
Sponsored by
About this trial
This is an interventional treatment trial for Brain Edema focused on measuring peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Barrow Neurological Institute
- UC San Diego Cancer Center
- Hoag Memorial Hospital Presbyterian
- Stanford University Medical Center
- UC Davis Medical Center
- University of Colorado Cancer Center
- Moffitt Cancer Center and Research
- Winship Cancer Institute, Emory University
- Northwestern University, Feinberg School of Medicine
- Evanston Northwestern Healthcare
- Beth Israel Deaconess Med Center
- Field Neurosciences Institute
- Neurology Group of Bergen County
- Dent Neurologic Institute
- Weill Medical College of Cornell University
- Wake Forest University
- University Hematology Oncology Care, LLC
- Good Samaritan Hospital
- The Ohio State University
- Oregon Clinic
- Methodist Healthcare - University Hospital
- Vanderbilt University Medical Center
- University of Wisconsin
- Medical College of Wisconsin
- Cross Cancer Institute
- Ottawa Regional Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
I
II
Arm Description
Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00226668
First Posted
September 23, 2005
Last Updated
December 27, 2007
Sponsor
Celtic Pharma Development Services
Collaborators
Neurobiological Technologies
1. Study Identification
Unique Protocol Identification Number
NCT00226668
Brief Title
XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Alternate study projected to assess imaging endpoints versus clinical endpoints.
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Celtic Pharma Development Services
Collaborators
Neurobiological Technologies
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Edema, Brain Tumor
Keywords
peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
Intervention Type
Drug
Intervention Name(s)
hCRF
Other Intervention Name(s)
XERECEPT (corticorelin acetate injection)
Intervention Description
hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
Intervention Type
Drug
Intervention Name(s)
placebo hCRF
Other Intervention Name(s)
placebo XERECEPT (corticorelin acetate injection)
Intervention Description
placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
Primary Outcome Measure Information:
Title
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.
Time Frame
Prospective
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Shapiro, MD
Organizational Affiliation
Barrow Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
UC San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Moffitt Cancer Center and Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Beth Israel Deaconess Med Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Field Neurosciences Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Neurology Group of Bergen County
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Facility Name
University Hematology Oncology Care, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Methodist Healthcare - University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1ZT
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
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