Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activa… (NCT03617003) | Clinical Trial Compass
CompletedPhase 1
Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)
United States30 participantsStarted 2018-08-01
Plain-language summary
The purpose of this study is to test the safety of a combination of the study drug called WST11 and PDT. Photodynamic therapy (PDT) is a type of ablation therapy (treatment which destroys tumor cells) which has been previously approved for the treatment of patients with other cancers. It works by using a drug that is given through the vein and then is activated in the tumor by light administered during endoscopy, which results in destruction of the cancer cells.
Who can participate
Age range18 Years
SexALL
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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
Exclusion Criteria:
* Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative…