VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

University of Michigan Rogel Cancer Center

Status and phase

Completed

Phase 4

Conditions

Carcinoma, Basal Cell

Treatments

Drug: Vismodegib

Study type

Interventional

Funder types

Other

Identifiers

NCT02436408

UMCC 2014.022

HUM00082579 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.