Understanding immune changes in basal cell carcinoma after light therapy
Alteration of the Immune Microenvironment in Basal Cell Carcinoma (BCC) Following Photodynamic Therapy (PDT)
This study is testing how light therapy affects the immune system in patients with basal cell carcinoma who are about to have surgery, by comparing treated and untreated tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05020912 on ClinicalTrials.gov |
What this trial studies
This study investigates how Photodynamic Therapy (PDT) affects the immune response in patients with basal cell carcinoma (BCC) who are scheduled for Mohs surgery. Participants will have one tumor treated with PDT and another left untreated to compare immune responses. The study aims to measure immune checkpoint molecules and the ratio of different T cell types in the tumors, as well as analyze circulating T-cells before and after treatment. The goal is to enhance understanding of PDT's potential to improve tumor clearance by altering the immune microenvironment.
Who should consider this trial
Good fit: Ideal candidates are adults with biopsy-proven basal cell carcinoma who are scheduled for Mohs surgery.
Not a fit: Patients who are pregnant, breastfeeding, or currently undergoing treatment for other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for basal cell carcinoma by harnessing the immune response.
How similar studies have performed: While PDT is not FDA-approved for BCC in the U.S., it has shown promise in European studies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Edward V Maytin, MD, PhD — Cleveland Clinic, Case Comprehensive Cancer Center
- Study coordinator: Edward V Maytin, MD, PhD
- Email: maytine@ccf.org
- Phone: 216-444-5139
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.