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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03617003|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : April 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Upper Tract Urothelial Carcinoma||Drug: WST11 mediated vascular targeted phototherapy (VTP) Procedure: Endoscopy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 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)|
|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 2023|
|Estimated Study Completion Date :||August 2023|
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.
Endoscopy of the bladder
- 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.
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
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jonathan Coleman, MD||Memorial Sloan Kettering Cancer Center|