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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03617003
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Upper Tract Urothelial Carcinoma Drug: WST11 mediated vascular targeted phototherapy (VTP) Procedure: Endoscopy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This a prospective, single institution, non-randomized open label phase 1 study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: phototherapy with WST11
Patients with urothelial cancer that includes involvement of the upper urinary tract and have failed prior endoscopic treatment, refuse standard treatment, or are ineligible for curative surgical resection of the kidney or ureter will be offered WST11 VTP treatment to be provided at the time of scheduled endoscopic procedure. At the time of endoscopy, patients will be treated with VTP therapy applied to the site of the tumor.
Drug: WST11 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.

Procedure: Endoscopy
Endoscopy of the bladder




Primary Outcome Measures :
  1. Maximum tolerated laser fluence rate [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617003


Contacts
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Contact: Jonathan Coleman, MD 646-422-4432 colemanj@mskcc.org
Contact: Dean Bajorin, MD 646-888-4700

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jonathan Coleman, MD    646-422-4432      
Contact: Dean Bajorin, MD    646-888-4700      
Principal Investigator: Jonathan Coleman, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jonathan Coleman, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03617003     History of Changes
Other Study ID Numbers: 18-140
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
WST-11
Phototherapy
18-140

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms