Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)
Case Comprehensive Cancer Center
Summary
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.
Description
This research study explores the effect of photodynamic therapy (PDT) on nonmelanoma skin cancers (NMSC). NMSC are made up of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). PDT is a treatment for NMSC that may be used instead of surgery. PDT uses light and a special chemical reaction to kill cancer cells on the skin's surface. First, an agent called aminolevulinate (ALA) is put on the skin of the tumor. Then, a bright blue light is shined on the skin, which causes a chemical reaction to occur. This chemical reaction helps to damage and kill cancer cells. NMSCs are common and ca…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Must provide informed consent to participate in the trial. * Participant must live in Ohio (Groups 2 \& 3), because Research Pharmacy cannot ship the study drugs out…
Interventions
- Dietary SupplementVitamin D (VitD)
Participants 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.
- OtherPlacebo
Participants 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.
- OtherPhotodynamic therapy (PDT)
PDT 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.
- ProcedureMohs surgery or electrodessication & curettage (ED&C) (standard of care)
Participants 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.
Location
- Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteCleveland, Ohio