Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
This research study is for people who have been diagnosed with a nonmelanoma skin cancer (either basal cell carcinoma or squamous cell carcinoma) and are planning to receive either Mohs surgery or ED\&C (electrodessication \& curettage) as part of clinical care. The purpose of this study is to understand how photodynamic therapy (PDT) with or without Vitamin D can promote an immune response to skin cancer.
For this study, participants will be randomized (randomly assigned) and asked to take Vitamin D or placebo for 6 days and come to the clinic for a single PDT treatment 1-14 days prior to their surgery. At this visit, photographs of participant's skin cancer will be taken, and participants will undergo PDT treatment. The study team will also take photos on the day of Mohs surgery or ED\&C. There will be up to two blood draws for research.
If participants do not want to come in for a PDT treatment prior to their Mohs surgery or ED\&C, they will have the option to participate by only allowing the study team to collect data about their skin cancer and their tissue from Mohs surgery or ED\&C.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be an adult participant (> 18 yrs) who is scheduled to undergo Mohs surgery or ED&C within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.
Must have at least one BCC or SCC tumor eligible for removal by Mohs surgery.
The original tumor size prior to biopsy must be >1.0 cm (in the longest diameter).
Participants of any ethnic group are eligible for this trial.
Disqualifiers
Pregnant or breastfeeding
Currently being treated for other cancers with medical or radiation therapy
Known hypersensitivity to 5-aminolevulinic acid
History of a photosensitivity disease, e.g., porphyria cutanea tarda
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin D (VitD)
Dietary supplementParticipants will orally take 10,000 international units daily of VitD for the 6 days prior to their scheduled PDT visit. Participants in Arms 2 and 3 will be blinded to whether they are receiving VitD or placebo.
Placebo
Other interventionParticipants will orally take a placebo (gelatin) capsule for the 6 days prior to their scheduled PDT visit. Participants in Arms 2 and 3 will be blinded to whether they are receiving VitD or placebo.
Photodynamic therapy (PDT)
Other interventionPDT involves a topical photosensitizing agent called aminolevulinate (ALA) being applied to the tumor surface. ALA is then activated by shining a blue light on the skin, causing a photodynamic reaction to occur. Participants will receive PDT 1-14 days prior to their scheduled Mohs surgery or ED\&C visit.
Mohs surgery or electrodessication & curettage (ED&C) (standard of care)
Procedure/SurgeryParticipants are eligible for this study by already planning to undergo Mohs surgery or ED\&C, which will be conducted per standard of care. For Arms 2 and 3, participants will undergo Mohs surgery or ED\&C 1-14 days after their PDT visit. For Arm 1, participants will undergo Mohs surgery or ED\&C at their scheduled time. All participants donate their discarded tissue from the Mohs surgery for research.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Participants donate discarded tissue for research (No VitD/Placebo + no PDT)Other 1 intervention
Group B: Arm 2: VitD + PDT prior to Mohs surgery or ED&CExperimental treatment 3 interventions
Group C: Arm 3: Placebo + PDT prior to Mohs surgery or ED&CPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
Expression of immune checkpoint molecules
Expression of immune checkpoint molecules will be compared in tumors and peri-tumoral stroma after photodynamic therapy (PDT) versus tumors without PDT and is defined as changes in the expression of PD-1, PD-L1, and TIM3, among other checkpoint inhibitors. This will be measured using the scRNA-seq data obtained from tumor tissues via Parse Biosciences scRNA-seq analysis.
Time frame
At time of Mohs surgery or ED&C, up to Day 20Secondary outcomes
1
Ratio of cytotoxic T cells to regulatory T cells
Ratio of cytotoxic T cells to regulatory T cells will be compared in tumors and peri-tumoral stroma after photodynamic therapy (PDT) versus tumors without PDT. This is measured using scRNA-seq data (Parse Bioscienes scRNA-sequencing kit).
Time frame
At time of Mohs surgery or ED&C, up to Day 202
Ratio of M1 macrophages to M2 macrophages
Ratio of M1 macrophages to M2 macrophages will be compared in tumors and peri-tumoral stroma after photodynamic therapy (PDT) versus tumors without PDT. This is measured using scRNA-seq data (Parse Bioscienes scRNA-sequencing kit).
Time frame
At time of Mohs surgery or ED&C, up to Day 203
Proportion of tumor-activated CD8+ T-cells in circulating T-cells
Proportion of tumor-activated CD8+ T-cells in circulating T-cells will be compared in tumors and peri-tumoral stroma after photodynamic therapy (PDT) versus tumors without PDT. This will be measured using peripheral blood analyzed using fluorescence-labelling and flow analysis (FACS)
Time frame
At time of Mohs surgery or ED&C, up to Day 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov