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

NCT05020912 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CASE2621
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Time to maximum expression of immune checkpoint molecules

  Time (days) to maximum expression of immune checkpoint molecules in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors. Data from frozen BCC specimens post-PDT by immunostaining the tumor specimens with antibodies against PD-L1, PD-1, CTLA-4 as well as the newer IC molecules TIGIT, TIM-3, and LAG-3

  at visit 2 (1-14 days)

• Altered expression of immune checkpoint molecules

  Altered expression of immune checkpoint molecules in BCC tumor specimens after PDT. Assessed by comparing IC molecule expression in PDT treated and untreated tumors with immunostaining in the tumor specimens with antibodies against PD-L1, PD-1, CTLA-4 as well as the newer IC molecules TIGIT, TIM-3, and LAG-3. (quantifying with immunofluorescence microscope)

  at visit 2 (1-14 days)

• Altered recruitment of different immune cell subtypes in BCC tumor specimens

  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. Measured with specific antibodies against the following markers, to determine the qualitative time course of infiltration by each immune cell populations: Neutrophils (Gr1+ or MPO+); Macrophages(F4/80+); MDSCs (CD33, S100A9); cytotoxicT-cells(CD8+); regulatory T-cells(CD4+,FoxP3+,CD25+, CD127-); NK natural killer cells(CD56+CD16+).

  at visit 2 (1-14 days)

Secondary Outcomes (8)

• Proportion of tumor-activated CD8+ T-cells after PDT

  at visit 2 (1-14 days)

• Rate of protoporphyrin IX (PpIX) accumulation in tumors

  Every 30 minutes up to 4 hours

• Maximal PpIX levels in tumors

  Every 30 minutes up to 4 hours

• Change in the color of tumors

  at visit 1 (pre PDT) and visit 2 (1-14 days)

• Change in the appearance of tumors

  at visit 1 (pre PDT) and visit 2 (1-14 days)

Study Arms (1)

Photodynamic therapy (PDT)

EXPERIMENTAL

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

Drug: ALA; Procedure: PDT

Interventions

ALA DRUG

At first visit, ALA applied to one BCC lesion

Also known as: Levulan

Photodynamic therapy (PDT)

PDT PROCEDURE

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

Photodynamic therapy (PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Aminolevulinic Acid; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Edward V Maytin, MD, PhD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward V Maytin, MD, PhD

CONTACT

216-444-5139; maytine@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will serve as their own control - one tumor will be PDT-treated and other left as untreated control

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: December 13, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)