Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)

Case Comprehensive Cancer Center (Case CCC)

Status: Not yet enrolling

Conditions: Squamous Cell Carcinoma; Nonmelanoma Skin Cancer; Basal Cell Carcinoma

Treatments: Other: Placebo; Procedure: Mohs surgery or electrodessication & curettage (ED&C) (standard of care); Dietary Supplement: Vitamin D (VitD); Other: Photodynamic therapy (PDT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07241585

CASE12Z25

5P01CA084203 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 can usually be cured with surgery. However, surgery can leave scars or result in disfigurement. This can be especially difficult for people who have tumors on their face or other visible or sensitive parts of the body. As an alternative to surgery, photodynamic therapy (PDT) is approved in Europe to treat BCC and SCC. However, because PDT does not work as well on thicker tumors, the U.S. FDA has not yet approved it for use on NMSC in this country. Investigators want to better understand how PDT damages and kills tumor cells, so that knowledge can be used to make the treatment more effective.

Vitamin D (VitD) is both a nutrient and a steroid-like hormone. Over 10+ years of research in investigators' laboratory has shown that VitD works well with PDT to treat NMSC. When participants receive a high dose of VitD before PDT, the treatment is able to clear the tumor more effectively. This has been shown in studies with mice that had early skin cancer, as well as mice with thick skin cancer. It has also been shown to be effective in participants with BCC. One reason that VitD may help is because it increases the amount of photosensitizing agent that can accumulate within the tumor, which helps to effectively kill cancer cells with PDT when light is applied. However, VitD has another important effect, which is that it helps to attract immune cells into the tumor. This effect has been seen in mouse models of SCC. The primary purpose of this study is to further investigate this immune mechanism in humans.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 outside of the state.

Exclusion criteria

• 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

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups, including a placebo group

Arm 1: Participants donate discarded tissue for research (No VitD/Placebo + no PDT)

Other group

Description:

Participants in Arm 1 will donate discarded tissue from their scheduled standard of care Mohs surgery or ED\&C. They will not be randomized to receive VitD or placebo and will not have PDT.

Treatment:

Procedure: Mohs surgery or electrodessication & curettage (ED&C) (standard of care)

Arm 2: VitD + PDT prior to Mohs surgery or ED&C

Experimental group

Description:

Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.

Treatment:

Other: Photodynamic therapy (PDT)

Dietary Supplement: Vitamin D (VitD)

Procedure: Mohs surgery or electrodessication & curettage (ED&C) (standard of care)

Arm 3: Placebo + PDT prior to Mohs surgery or ED&C

Placebo Comparator group

Description:

Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.

Treatment:

Other: Photodynamic therapy (PDT)

Procedure: Mohs surgery or electrodessication & curettage (ED&C) (standard of care)

Other: Placebo