Ann Arbor, Michigan 48109


Purpose:

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.


Criteria:

Inclusion Criteria: - Adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the lacrimal drainage system. - Clinical assessment score obtained at baseline. - Medical Oncology screening performed at baseline. - Adequate BCCA size and location. - Adequate hematopoietic capacity, hepatic and renal function. - Male patients must agree to use condoms during treatment and for 2 months after last dose. - Male patients must agree to not donate sperm during treatment and for 2 months after last dose. - Participant must agree not to donate blood during the study and for 7 months after last dose. - Informed consent signed. - Patient must consent to blood biomarker analysis. - Patient must be able to be present for monthly visits for the duration of the study. Exclusion Criteria: - Inability or unwillingness to swallow capsules. - Inability or unwillingness to comply with study procedures. - Pregnant, lactating, or breast feeding women. - Women of childbearing potential. - Uncontrolled medical illness. - Age under 18 years.


NCT ID:

NCT02436408


Primary Contact:

Principal Investigator
Alon Kahana, M.D., Ph.D.
University of Michigan

Alon Kahana, M.D.. Ph.D.
Phone: 734-936-8654
Email: akahana@med.umich.edu


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States

Alon Kahana, M.D., Ph.D.
Phone: 734-936-8654
Email: akahana@med.umich.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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