Clinical Trial: XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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<
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 Summary: XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Sponsor: Celtic Pharma Development Services
Current Primary Outcome: 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 ]
Original Primary Outcome:
- The primary efficacy endpoint is the proportion of reponders, 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. Improvement is defined as:
- -Lower overall score on the 10-item Neurological Exam of at least 25% relative to Baseline, and
- -Karnofsky Performance Score unchanged or increased relative to Baseline, and
- -No post-Baseline increase in dexamethasone dose on more than 1 day, with a maximum allowable increase of less than 4mg on that day.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Celtic Pharma Development Services
Dates:
Date Received: September 23, 2005
Date Started: January 2006
Date Completion: January 2008
Last Updated: December 27, 2007
Last Verified: December 2007
