A Phase I Study of WST-11 Light-Activated Therapy for Kidney and Ureter Cancers

Full Title

Phase I Study of WST-11 Phototherapy for Upper Tract Urothelial Carcinoma

Purpose

Photodynamic therapy (PDT) is one way to treat cancer. The patient receives a drug (by vein) that circulates throughout the body. When laser light is applied to the tumor through a scope, the drug becomes activated inside the tumor to kill cancer cells. This treatment can cause side effects because the drug can stay in the body for several hours, and patients can develop a sunburn when exposed to sunlight. For this reason, patients who receive this kind of therapy are required to avoid exposure to direct sunlight for some time after their treatment.

In this study, researchers are evaluating a new approach called vascular-targeted photodynamic therapy (VTP) using a drug called WST-11 (Tookad) in patients with cancer of the kidney or ureter (the tube that carries urine from the kidney to the bladder) that has not responded to prior treatment. 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 treat persistent kidney and ureter cancers. The light will be applied through a cystoscope (a scope inserted into the bladder via the urethra) using a laser fiber.

Eligibility

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

  • Patients must have renal pelvis or ureter cancer that remains despite prior endoscopic treatment.
  • Patients may not be eligible for cancer surgery or must have refused this treatment.
  • At least 4 weeks must pass between the completion of any prior chemotherapy, immunotherapy, or biologic therapy and entry into the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Jonathan Coleman at 646-422-4432 or Dr. Dean Bajorin at 646-422-4333.

Protocol

18-140

Phase

I

Disease Status

Newly Diagnosed

Investigator

Coleman, Jonathan, MD

Co-Investigators