A Phase I Study of a New Type of Photodynamic Therapy for Patients with Esophageal Cancer and Trouble Swallowing

Full Title

A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients with Moderate to Severe Dysphagia

Purpose

Photodynamic therapy (PDT) is one way to treat obstructions in the esophagus that hinder swallowing in patients with esophageal cancer. The patient receives a drug (by vein) that circulates throughout the body. When laser light is applied to the tumor during endoscopy, the drug becomes activated to kill cancer cells. However, this treatment can cause side effects because the drug stays in the body for days, and patients can develop sunburn when exposed to sunlight or other bright lights. In addition, not everyone benefits from this treatment.

In this study, researchers are evaluating a new approach called vascular-targeted photodynamic therapy (VTP) using a drug called WST-11. WST-11 stays in the blood vessels and does not get into individual cells in the body. It also leaves the body faster, so patients can be exposed to sunlight safely within a few hours of treatment.

Investigators in this study are evaluating different doses of laser light that can be used with VTP to relieve esophageal obstructions in people with esophageal cancer. They will also assess its effectiveness against the tumor in the esophagus as well as cancer elsewhere in the body. Since VTP may stimulate an immune response, they will analyze each patient’s immune response following treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have esophageal cancer that is causing moderate to severe trouble swallowing.
  • At least 1 week must pass between the completion of prior therapy and entry into the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Hans Gerdes at 212-639-7108.

Protocol

15-319

Phase

I/II

Investigator