Clinical Trial: VISmodegib for ORbital and Periocular Basal Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

Brief Summary:

Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat.

Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required

In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care.


Detailed Summary:
Sponsor: University of Michigan Cancer Center

Current Primary Outcome: The number of patients with a score of 21 or greater by the Visual Assessment Weighted Score (VAWS) at 1 year [ Time Frame: 1 year ]

The VAWS was developed for the purpose of this study. It is made up of standard ophthalmic exam points, as well as subjective assessment of tearing and overall patient satisfaction. The maximum score is 50 and a score of 21 or greater will be considered a good outcome


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Michigan Cancer Center

Dates:
Date Received: May 1, 2015
Date Started: May 2015
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016