PDT-MDS-BCC-24

Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas

Study Description

Blue light PDT has shown some success in treating BCCs, but more research is needed to evaluate this treatment modality further. The objective of this study is to evaluate the safety and efficacy of using photodynamic Therapy with Sonidegib for the treatment of multiple nodular basal cell carcinomas. Participants who meet eligibility criteria at baseline will receive Sonidegib 200 mg by mouth every day for 3 months. Participants will undergo three PDT sessions with topical application of ALA at Day 7, Day 30, and Day 90.

Brief Summary

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.

Condition or Disease

Basal Cell Carcinoma

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	20
Primary Outcome Measures	1. Primary efficacy outcome measure: the overall response rate (ORR) to the combination therapy in patients, which is the proportion of evaluable study subjects who has complete response (CR) or partial response (PR) to the study treatment as defined in the protocol. 2. Primary safety outcome measure: the proportion of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event (SAE, as defined in Section 5.1) that&#39;s determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.
Actual Study Start Date:	October 2024
Estimated Primary Completion Date:	December 2026

Eligibility Criteria

Ages Eligible for Study:	18 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Basal Cell Carcinoma

Inclusion Criteria

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

Exclusion Criteria

Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
Any BCC that may require Mohs surgery for definitive control
Subjects with porphyria’s or known hypersensitivity to porphyrins
Subjects with known photosensitivity diseases
Subjects previously treated with a systemic photosensitizer within 4 months of screening date
Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

ADDITIONAL DETAILS

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