This phase IV trial studies how well vismodegib works in treating patients with orbital or periocular basal cell cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has come back (recurrent). Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02436408.
PRIMARY OBJECTIVES:
I. To determine whether treatment with vismodegib of patients with locally advanced or recurrent orbital and/or periocular basal cell carcinoma (BCCA) will be associated with good ophthalmic outcomes, as measured using a novel Visual Assessment Weighted Score.
SECONDARY OBJECTIVES:
I. To assess individual parts of the composite Visual Assessment Weighted Score to independently assess vision and lacrimal function after treatment.
II. To correlate visual function to location and size of tumor over the course of treatment.
III. To identify histologic characteristics of periocular BCCA that correlate with tumor response.
IV. To characterize molecular markers that may identify opportunities for developing adjunct treatment approaches for recalcitrant tumors.
V. To characterize and validate the Visual Assessment Score for use in future investigations of orbital disorders.
OUTLINE:
Patients receive standard of care (SOC) vismodegib orally (PO) once daily (QD). Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months and then every 3 months thereafter.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorAlon Kahana
