Alteration of the Immune Microenvironment in Basal Cell Carcinoma (BCC) Following Photodynamic Therapy (PDT)
Case Comprehensive Cancer Center
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.
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, becau…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugALA
At first visit, ALA applied to one BCC lesion
- ProcedurePDT
PDT with blue light (for 30 min (\~20 mJ/cm2))
Location
- Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, Ohio