Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)

Inclusion Criteria

• •Age 18 or older
• •* Confirmed tissue diagnosis of urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at MSKCC
• •* Residual or recurrent cancer following prior endoscopic treatment
• •* Ineligible, unwilling or refusing to undergo surgical management by resection of involved kidney or ureter.
• •* Karnofsky performance status ≥ 50%
• •* Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted. Demonstration of the site and degree of obstruction must be documented by retrograde pyelography at the time of initial and follow up endoscopic procedures within 60 days.
• •* Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) ≤4 weeks prior to treatment
• •* Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2)
• •* Adequate organ function defined at baseline as:
• •* ANC ≥1,000/ µL
• •* Platelets ≥75,000/ µL
• •* Hb ≥9 g/dl
• •* INR ≤1.5 (except for patients who are on full-dose warfarin)
• •* Calculated creatinine clearance ≥40 ml/min (using Cockcroft-Gault method)
• •* Total serum bilirubin ≤1.5 mg/dL
• •* AST/ALT ≤5× upper limit of normal
• •* Able to provide written informed consent