Have you or your loved ones been diagnosed with upper tract urothelial carcinoma?

You may be eligible to participate in a upper tract urothelial carcinoma clinical trial.

Have you or your loved ones been diagnosed with upper tract urothelial carcinoma? You may be eligible to participate in a upper tract urothelial carcinoma clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Upper Tract Urothelial Carcinoma Clinical Trial in New York NY

NCT03617003 | Phase 1 | Interventional

Have you or your loved ones been diagnosed with upper tract urothelial carcinoma?

You may be eligible to participate in a upper tract urothelial carcinoma clinical trial.

Have you or your loved ones been diagnosed with upper tract urothelial carcinoma? You may be eligible to participate in a upper tract urothelial carcinoma clinical trial.

Active not recruiting

Male & Female

18 Years +

This study has recruited 30 Participants

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.

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Details for the study

Brief Title

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

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.

Treatments and/or Procedures

WST 11 mediated vascular targeted phototherapy VTP

All patients will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes while patients are under anesthesia during their endoscopy procedure, followed by immediate laser light application.

Endoscopy

Endoscopy of the bladder

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Maximum tolerated laser fluence rate

The MTD will be defined as the dose whose toxicity rate does not exceed an acceptable threshold of toxicity 20%.in this study, we shall start at 100mW/cm and will carefully escalate the dose to a maximum of 200 mW/cm.

2 years

Study 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