RecruitingPhase 2NCT03945162

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients

A Phase II Clinical Study of Intravesical Ruvidar® in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") or Patients Who Are Intolerant to BCG Therapy ("Study II")

Sponsor

Theralase® Technologies Inc.

Enrollment

90 participants

Start Date

Aug 30, 2019

Study Type

INTERVENTIONAL

Conditions

Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG

Summary

This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a light-based treatment called photodynamic therapy (PDT) delivered directly into the bladder for people with a type of bladder cancer (non-muscle-invasive bladder cancer) that has not responded to BCG — a common first-line bladder cancer treatment. PDT uses a light-activated drug to selectively destroy cancer cells. **You may be eligible if...** - You are over 18 years old - You have high-grade non-muscle-invasive bladder cancer (including carcinoma in situ) confirmed by biopsy - Your bladder cancer has not responded to or you cannot tolerate BCG treatment - Your kidneys function well enough to drain the therapy from your bladder **You may NOT be eligible if...** - Your bladder cancer has spread into the muscle wall or beyond - You have a urinary tract infection or obstruction - You are taking blood-thinning medications that cannot be safely stopped - You are pregnant or breastfeeding - You have a known allergy to the photodynamic therapy drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTRuvidar® (TLD-1433) bladder infusion and PDT

Ruvidar® (TLD-1433) is infused into the bladder and treatment of bladder wall with PDT light activation using the TLC-3200 system.

Locations(16)

Site 02-012 - University of Chicago

Chicago, Illinois, United States

Site 02-016 - Urology of Indiana

Greenwood, Indiana, United States

Site 02-015 - Associated Medical Professionals of New York

Syracuse, New York, United States

Site 02-017 - Central Ohio Urology Group

Gahanna, Ohio, United States

Site 02-008 - MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Site 02-006 - Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site 02-007 - Urology Associates, P. C

Nashville, Tennessee, United States

Site 02-010 - Urology San Antonio P. A

San Antonio, Texas, United States

Site 02-009 - Virginia Urology

Richmond, Virginia, United States

Site 02-011 - University of Wisconsin Health University Hospital

Madison, Wisconsin, United States

Site 01-005 - The Vancouver Prostate Centre - Diamond Health Care Centre - Vancouver General Hospital

Vancouver, British Columbia, Canada

Site 01-004 - Nova Scotia Health Authority - Centre for Applied Urology Research

Halifax, Nova Scotia, Canada

Site 01-014 - St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site 01-002- London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Site 01-001 - University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site 01-003 - McGill University Health Centre - Glen-Cedars Cancer Centre

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03945162