Clinical Trial: Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Open-Label, Imaging Study of Human Corticotropin-Releasing Factor (hCRF) for The Reduction of Peritumoral Brain Edema (PBE) in Patients With Primary Malignant or Metastati

Brief Summary: This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days

Detailed Summary: The purpose of this study is to investigate the effect of 3 different regimens of subcutaneous (SC) administered hCRF (1.0 mg every [Q] 8 hours [h], 1.5 mg Q12h, and 1.0 mg Q12h) on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes.
Sponsor: PharmaNet

Current Primary Outcome:

Original Primary Outcome: To investigate the effect of 3 different regimens SC of hCRF on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes. [ Time Frame: MRI-derived measurements of the differences in mean diffusivity ]

Current Secondary Outcome:

Original Secondary Outcome: To evaluate the safety of hCRF in the treatment of PBE patients with primary malignant or metastatic brain tumors To establish the percentage of responders as measured by clinical and radiographic means To identify tumor and PBE changes [ Time Frame: General laboratory, physical and neurological examinations, AEs/SAEs ]

Information By: PharmaNet

Dates:
Date Received: June 2, 2008
Date Started: November 2008
Date Completion: October 2009
Last Updated: January 8, 2009
Last Verified: January 2009