This clinical trial evaluates how photodynamic therapy, with or without vitamin D, affects the immune response in patients with basal cell or squamous cell skin cancer. Photodynamic therapy is a medical treatment that combines a photosensitizing agent (a drug that becomes active when exposed to light) with specific wavelengths of light to destroy cancerous and precancerous cells. While photodynamic therapy is approved for treating certain pre-cancers of the skin, it is not yet approved for the treatment of basal cell or squamous cell cancers. Vitamin D has been shown to enhance the effectiveness of photodynamic therapy by increasing the accumulation of the photosensitizing agent and enhancing the recruitment of immune cells into the tumor. Combining photodynamic therapy with vitamin D supplementation may alter the tumor environment by increasing the expression of immune cells and molecules in patients with basal cell or squamous cell skin cancers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07241585.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Edward Maytin
Phone: 216-346-6022
PRIMARY OBJECTIVE:
I. To determine whether the expression of immune checkpoint molecules is increased in basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) 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 non-melanoma skin cancer (NMSC) tumors and peri-tumoral stroma after PDT, as compared to tumors without PDT.
II. To determine the ratio of M1 macrophages to M2 macrophages in NMSC tumors and peri-tumoral stroma after PDT, as compared to tumors without PDT.
III. To determine whether circulating T-cells, collected from the peripheral blood of patients who have received PDT, show a higher proportion of tumor-activated CD8+ T-cells after PDT than patients who received no PDT.
OUTLINE: Patients who are able to participate in the complete version of the study are randomized to group 2 or group 3 and all other patients are assigned to group 1.
GROUP 1: Patients undergo Mohs surgery.
GROUP 2: Patients receive placebo orally (PO) once daily (QD) for 6 days and then receive aminolevulinic acid (5-ALA) topically and undergo PDT 4 hours later. Within 14 days of completing PDT, patients undergo Mohs surgery. Patients may optionally undergo collection of blood samples on study.
GROUP 3: Patients receive vitamin D PO QD for 6 days and then receive 5-ALA topically and undergo PDT 4 hours later. Within 14 days of completing PDT, patients undergo Mohs surgery. Patients may optionally undergo collection of blood samples on study.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorEdward Maytin
