Study on How Photodynamic Therapy Affects the Immune System in Basal Cell Carcinoma

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05020912

Provider View

This study aims to understand how the immune system responds to basal cell carcinoma (BCC) when treated with Photodynamic Therapy (PDT). Researchers hope to find new ways to treat BCC by learning how PDT might improve tumor removal when used with other treatments.

Patient Parameters

Program Overview

The study is focused on understanding how Photodynamic Therapy (PDT) affects the immune response in patients with basal cell carcinoma (BCC). PDT uses a special light and a topical agent to kill cancer cells. Although not approved by the FDA for BCC in the U.S., it is used in Europe. The study will involve 24 participants who are scheduled for Mohs surgery to remove BCC. One tumor will be treated with PDT, while another will not, to compare the immune response. Researchers will analyze tissue samples to learn more about how the immune system reacts to PDT and if it helps in fighting the cancer.

Description

Photodynamic Therapy (PDT) is a treatment that uses a light-sensitive drug and a special light to destroy cancer cells. While not FDA-approved for basal cell carcinoma (BCC) in the U.S., it is used in Europe. This study will include 24 participants with BCC who are planning to have their tumors removed through Mohs surgery. Each participant will have one tumor treated with PDT and another left untreated for comparison. The study will also use tissue samples from other patients who have had Mohs surgery to understand the natural immune response in untreated tumors.

The study aims to:

  • Find out how quickly immune checkpoint molecules appear in BCC tumors after PDT compared to untreated tumors.
  • Compare the number of different types of T cells in treated and untreated tumors.
  • See if T cells in the blood show more activity against tumors after PDT.
  • Measure how much of a certain chemical (PpIX) builds up in tumors and how much oxygen is produced during PDT.
  • Observe changes in the size, color, and appearance of tumors after PDT.
  • Check for any effects on other tumors in the body after PDT.

Eligibility Criteria

Inclusion Criteria

  • Adults scheduled for Mohs surgery at the Cleveland Clinic's Dermatologic Surgery unit.
  • Must have at least one BCC tumor that can be removed by surgery.
  • Open to men and women of any ethnic background.
  • Must agree to participate and provide informed consent.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Currently receiving treatment for other cancers with medication or radiation.
  • Known allergy to 5-aminolevulinic acid (ALA).
  • History of diseases that cause sensitivity to light, like porphyria cutanea tarda.

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