Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy

NCT ID: NCT05020912

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2027-12-31

Brief Summary

The purpose of this study is to better understand the immune response to basal cell carcinoma (BCC) treated with Photodynamic Therapy (PDT) in order to develop new methods of treating BCC. Previous research suggests that PDT alters the immune response, possibly in a way that could promote better tumor clearance when combined with other treatments. Overall, participation in this study will help the study team better understand the anti-tumor immune response when BCC is treated with PDT.

Detailed Description

PDT is a technique that works by combining a photosensitizing topical agent and an intense light to kill tumor cells. PDT is not currently approved for the treatment of BCC by the Food and Drug Administration (FDA), although it is approved for that purpose in many European countries.

This is an internally (bilaterally) controlled trial that will enroll 24 participants with biopsy-proven BCC who are planning to undergo tumor removal via Mohs surgery. Within this cohort, one tumor will be PDT-treated and the other left as an untreated control. This study is also a cohort-controlled trial, because discarded tissue from fully de-identified Mohs participants will be analyzed after routine Mohs surgery, in order to establish the baseline variability in tumor-infiltrating immune cell parameters in non-PDT-treated participants.

The objectives of this study are:

To determine the time to maximum expression of immune checkpoint molecules in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors.

To determine the ratio of cytotoxic T cells to regulatory T cells in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors.

To determine whether circulating T-cells, collected from patients' peripheral blood, sampled before and after PDT treatment of a BCC tumor, show a higher proportion of tumor-activated CD8+ T-cells after PDT. The hypothesis is that PDT of the localized tumor will trigger a systemic anti-tumor immune effect.

To determine the rate of protoporphyrin IX (PpIX) accumulation and maximal PpIX levels.in tumors To determine the rate of production and maximal levels of singlet oxygen (O2) produced during blue light exposure To assess change in the volume, color, and appearance of tumors at the Mohs surgery visit compared to the PDT visit To assess for distant tumor (abscopal) effects after PDT

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photodynamic therapy (PDT)

Each participant will serve as their own control, receiving PDT for one tumor, no PDT for the second tumor (untreated control).

Visit 1:

• Informed consent
• Blood draw
• Lesion(s) Photographed
• (ALA) applied for4 hours
• PpIX measured in lesions (PpIX buildup monitored every 30 minutes over a 4 h period)
• PDT with blue light

Visit 2 (scheduled for within one of the following time intervals: 1-3 days, 4-7 days, or 8-14 days post-PDT):

• Blood draw
• Lesion(s) Photographed
• Mohs surgery
• After procedure, excess frozen BCC tissue will be saved for analysis

Group Type: EXPERIMENTAL

ALA

Intervention Type: DRUG

At first visit, ALA applied to one BCC lesion

PDT

Intervention Type: PROCEDURE

PDT with blue light (for 30 min (\~20 mJ/cm2))

Interventions

ALA

At first visit, ALA applied to one BCC lesion

Intervention Type: DRUG

PDT

PDT with blue light (for 30 min (\~20 mJ/cm2))

Intervention Type: PROCEDURE

Other Intervention Names

Levulan

Eligibility Criteria

Inclusion Criteria

• Adults scheduled to undergo Mohs surgery within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic
• Must have at least one BCC tumor eligible for removal by surgical excision
• Men and women of any ethnic group are eligible
• Must provide informed consent to participate

Exclusion Criteria

• Pregnant or breastfeeding
• Currently being treated for other cancers with medical or radiation therapy
• Known hypersensitivity to 5-aminolevulinic acid (ALA)
• History of a photosensitivity disease, e.g.,porphyria cutanea tarda

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward V Maytin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edward V Maytin, MD, PhD

Role: CONTACT

maytine@ccf.org

216-444-5139

Facility Contacts

Edward V Maytin, MD, PhD

Role: primary

maytine@ccf.org

216-444-5139

Other Identifiers

CASE2621

Identifier Type: -

Identifier Source: org_study_id