VISmodegib for ORbital and Periocular Basal Cell Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/2/2018 |
| Start Date: | May 2015 |
| End Date: | August 2020 |
| Contact: | Alon Kahana, M.D.. Ph.D. |
| Email: | akahana@med.umich.edu |
| Phone: | 734-936-8654 |
VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)
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.
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.
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 3 months after last
dose.
- Male patients must agree to not donate sperm during treatment and for 3 months after
last dose.
- Participant must agree not to donate blood during the study and for 7 months after
last dose.
- Informed consent signed.
- If the patient consents to enroll, then blood will be drawn and stored for biomarker
analysis.
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.
- Dementia or significantly altered mental status that would prohibit the understanding
or rendering of informed consent and compliance with the requirements of this
protocol.
- Age under 18 years.
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