Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions. Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion. These types of treatment can cause scarring. Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart. The light used can cause the skin to feel warm, but does not cause scarring.
‣ Patients will be included in the study based on the following criteria:
• Male or females, at least 18 years of age
• Diagnosis of BCC with at least 3 nodular lesions that measure 0.5 cm to 5 cm in diameter, located on the head and neck, trunk or extremities.
• Diagnosis must be confirmed clinically at baseline with 1-2 lesions having been biopsied no sooner than 2 weeks prior to treatment.
• Patients who may have high burden of disease ie large lesions, who are non-surgical candidates or who refuse surgery.
• Non-surgical candidates, who may be able to undergo resection of selected single, individual lesion, but may not tolerate extensive surgery, may have many co morbidities, may be prone to complications.
• Patients in whom surgery or radiation therapy may be impractical
• Primary lesions may be acceptable for enrollment
• Within normal limit hematopoietic capacity, hepatic and renal function. Values outside those limits may be allowed at the discretion of the PI, if they are determined as not clinically significant
• Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
⁃ Ability to understand and the willingness to sign a written informed consent document in English