Clinical trial NCT03617003: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)
Official title: Phase I Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Upper Tract Urothelial Carcinoma
Keywords: WST-11
Phototherapy
18-140
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This a prospective, single institution, non-randomized open label phase 1 study.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include:

  * Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months)
  * Women on hormone replacement therapy with documented serum follicle stimulating hormone level \> 35 mIU/ml
  * Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence or where the partner is sterile
* T4 tumors with involvement of the bowel or major blood vessels • Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease that, in the opinion of the study investigator, would make the patient a poor candidate for the study

Primary outcomes:
measure: Maximum tolerated laser fluence rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonathan Coleman, MD
role: PRINCIPAL_INVESTIGATOR
References: