A Study of Immune Response to Photodynamic Therapy in Patients with Basal Cell Carcinoma

PRIMARY OBJECTIVE:

I. To determine the time to maximum expression of immune checkpoint molecules in basal cell carcinoma (BCC) tumors and peri-tumoral stroma after photodynamic therapy (PDT), as compared to tumors without PDT.

SECONDARY OBJECTIVES:

I. To determine the ratio of cytotoxic T cells to regulatory T cells in BCC tumors and peri-tumoral stroma after PDT, as compared to tumors without PDT.

II. To determine whether circulating T-cells, collected from patients’ peripheral blood, sampled before and after PDT applied to a BCC tumor, show a higher proportion of tumor-activated CD8+ T-cells after PDT.

III. To determine the rate of protoporphyrin IX (PpIX) accumulation and maximal PpIX levels in tumors.

IV. To assess change in the volume, color, and appearance of tumors at the surgery visit compared to the PDT visit.

V. To assess for distant tumor (abscopal) effects after PDT.

VI. To determine the association of PDT with expression of immune- and cancer-associated ribonucleic acid (RNA) molecules using NanoString nCounter, a multiplex platform for RNA quantification.

OUTLINE:

Patients undergo application of aminolevulinic acid (ALA) to 1 BCC lesion. After 4 hours, the ALA applied lesion is exposed to Blue Light PDT over 30 minutes. Patients then undergo standard of care surgery for all lesions at either 1-3 days, 4-7 days, or 8-14 days. Patients also undergo blood sample collection on the study.