VISmodegib for ORbital and Periocular Basal Cell Carcinoma
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
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.
Patients with tumors that do not respond to treatment with Vismodegib, and those who have a
good response but poor tolerance of Vismodegib, will be offered surgical excision of the
tumor. Patients with a good response and good tolerance of Vismodegib may continue the
treatment as long as clinically indicated.
Phase:
Phase 4
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center