XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00226668
• Other study ID #: NTI 0302
• Secondary ID: corticorelin ace
• Status: Withdrawn
• Phase: Phase 3
• First received: September 23, 2005
• Last updated: December 27, 2007
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: December 2007
• Source: Celtic Pharma Development Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 120
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Edema
• Brain Neoplasms
• Brain Tumor
• Edema

Intervention

Drug:
• hCRF
hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
• placebo hCRF
placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
United States	Dent Neurologic Institute	Amherst	New York
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Beth Israel Deaconess Med Center	Boston	Massachusetts
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	University Hematology Oncology Care, LLC	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	UC San Diego Cancer Center	La Jolla	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Methodist Healthcare - University Hospital	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Medical College of Cornell University	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Stanford University Medical Center	Palo Alto	California
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Clinic	Portland	Oregon
United States	Neurology Group of Bergen County	Ridgewood	New Jersey
United States	UC Davis Medical Center	Sacramento	California
United States	Field Neurosciences Institute	Saginaw	Michigan
United States	Moffitt Cancer Center and Research	Tampa	Florida
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Celtic Pharma Development Services	Neurobiological Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes