Study on Using Light Therapy After Radiation to Treat Inoperable Cancer Blocking the Airways

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06306638

Provider View

This clinical trial is exploring a new treatment that combines light therapy with radiation to help patients who have cancer blocking their airways and cannot have surgery. The study aims to see if this approach can improve breathing and reduce the risk of complications without causing severe side effects.

Patient Parameters

Program Overview

This study is testing a new treatment for patients with advanced cancer that blocks the airways, making it hard to breathe. The treatment combines radiation therapy with a special light therapy called photodynamic therapy (PDT). PDT involves injecting a light-sensitive drug into the bloodstream, which collects in the tumor. A red laser light is then used to activate the drug, aiming to shrink the tumor and improve breathing. The goal is to see if this combination can help control the tumor and improve survival without the severe side effects of high-dose radiation alone.

Description

The study is divided into two phases. In Phase I, the focus is on testing the safety of using light therapy guided by imaging techniques after standard radiation treatment. In Phase II, the effectiveness of this approach is evaluated.

In Phase I, patients are divided into two groups. Group 1 receives a drug called visudyne through an IV, followed by light therapy using a special ultrasound technique. This is done up to three times. Group 2 receives standard radiation treatment first, then the same visudyne and light therapy as Group 1, but only twice and spaced 12 weeks apart. Both groups have blood and tissue samples collected and undergo CT scans during the study.

In Phase II, all patients receive standard radiation treatment, followed by visudyne and light therapy twice, spaced 12 weeks apart. Blood and tissue samples are collected, and CT scans are performed throughout the study.

After completing the treatment, patients are monitored at 30 days, and then at 8, 12, and 24 weeks to check their progress and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a type of cancer that blocks the airways and cannot be treated with surgery.
  • Must be able to receive radiation therapy and light therapy as determined by doctors.
  • Must have at least one tumor that can be measured by scans.
  • Must be able to undergo a high-resolution chest CT scan.
  • Must have a performance status score of 3 or less, indicating some ability to perform daily activities.
  • Must have adequate blood cell counts and normal blood clotting times.
  • Women of childbearing potential must agree to use effective birth control during the study and for 3 months after.
  • Must understand the study and agree to sign a consent form.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Have eye conditions that require certain exams soon after treatment.
  • Have conditions that make them unsuitable for light therapy.
  • Have tumors invading major blood vessels.
  • Have allergies to the drug used in light therapy.
  • Not cleared for anesthesia needed for the procedure.
  • Have a condition called porphyria.
  • Have an egg allergy.
  • Unwilling or unable to follow study requirements.

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