This phase I trial studies the best dose and side effect of laser light fluence rate, and how well it works with padeliporfin in treating patients with ureter and/or renal pelvis urothelial cancer that has come back (recurrent). Phototherapy uses a drug, such as padeliporfin, that becomes active when it is exposed to light. The activated drug may kill tumor cells in patients with ureter and/or renal pelvis urothelial cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03617003.
PRIMARY OBJECTIVE:
I. To determine the maximally tolerated laser light fluence rate (mE/cm) for padeliporfin (WST-11) mediated phototherapy vascular targeted phototherapy (VTP) in the upper urinary tract in the treatment of patients with upper tract urothelial carcinoma (UTUC).
SECONDARY OBJECTIVES:
I. To assess the efficacy of VTP treatment as primary for UTUC, based on the response of the target treatment site.
II. To evaluate serum markers of immune response following VTP treatment of UTUC.
III. To evaluate urinary markers of response following VTP for UTUC.
IV. Evaluate kidney preservation status of the treated kidney.
OUTLINE: This is a dose-escalation study of laser light fluence rate for VTP.
Patients receive padeliporfin intravenously (IV) over 10 minutes during their endoscopy procedure, then immediately undergo VTP therapy over 10 minutes on day 0.
After completion of study treatment, patients are followed up at 30 days and at 6 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJonathan Andrew Coleman