NCT00226668

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Celtic Pharma Development Services · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Edema
• Brain Tumor

Interventions

Type	Name	Description
DRUG	hCRF	hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
DRUG	placebo hCRF	placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking

Timeline

• Start date: 2006-01-01
• Completion: 2008-01-01
• First posted: 2005-09-27
• Last updated: 2008-01-03

Locations

26 sites across 2 countries: United States, Canada