A Phase III Study of Padeliporfin Vascular Targeted Photodynamic Therapy in People with Upper Tract Urothelial Cancer

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Full Title

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Purpose

Padeliporfin VTP (vascular targeted photodynamic) therapy uses targeted laser light to destroy cancer cells while causing minimal damage to the tissues around the cancer. In this study, researchers want to learn if padeliporfin VTP therapy is effective and safe for people with low-grade upper urothelial cancers (tumors of the kidney or ureter) that have not spread.

Photodynamic therapy is a two-part process. First the drug, padeliporfin, is injected into a vein. Then it is activated at the tumor site using light from a laser. When the drug is turned on, it destroys the vessels that supply blood to the tumor, which may cause the rapid death of cancer cells.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have low-grade non-invasive upper urothelial tract cancer (kidney or ureter).
  • If the patient had prior treatment, at least two months must pass between the completion of therapy and the receipt of photodynamic therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Jonathan Coleman at 646-422-4432.

Protocol

21-321

Phase

Phase III (phase 3)

Investigator

Co-Investigators

Jonathan Coleman

ClinicalTrials.gov ID

NCT04620239