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Photosensitizer
PDT for Bladder Cancer
Phase 2
Recruiting
Led By Girish Kulkarni, MD, FRCSC
Research Sponsored by Theralase Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are not candidates for cystectomy on medical grounds or refuse radical cystectomy
Intolerant to BCG or considered BCG-Unresponsive, which 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study ii and up to the completion of the follow-up phase (15 month)
Awards & highlights
Study Summary
This trial is for patients with bladder cancer who have not responded to other treatments or who can't tolerate other treatments. The trial will consist of 100 patients who will have two treatments of a new drug.
Who is the study for?
This trial is for adults with non-muscle invasive bladder cancer who can't tolerate or haven't responded to BCG therapy. They must be able to hold the study drug in their bladder for at least 60 minutes, not have plans for a cystectomy, and women of childbearing age must use birth control or abstain from sex. People are excluded if they've had certain treatments recently, have active bleeding in urine, anesthesia risks, other cancers needing treatment (with some exceptions), or an active infection.Check my eligibility
What is being tested?
The trial tests Ruvidar® (TLD-1433) infused into the bladder followed by photodynamic therapy on patients with NMIBC who don’t respond to BCG treatment. It's an open-label phase II study across Canada and the US involving around 100-125 patients receiving two PDT treatments six months apart.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones related to intravesical therapies include discomfort during infusion, potential bladder irritation leading to symptoms like pain during urination or increased frequency/urgency of urination. Photodynamic therapy may cause localized tissue damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot or do not want to undergo major bladder surgery.
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I am intolerant to BCG or it did not work for me despite receiving multiple doses.
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I can hold my bladder for at least 60 minutes.
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I am a woman who can have children and have a negative pregnancy test.
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I am a woman who can have children and have a negative pregnancy test.
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I am over 18 years old.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study ii and up to the completion of the follow-up phase (15 month)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study ii and up to the completion of the follow-up phase (15 month)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy, evaluated by Complete Response ("CR").
Secondary outcome measures
Efficacy, evaluated by the duration of CR
Other outcome measures
Safety, evaluated by the incidence and severity of Adverse Events.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 0.7 mg/cm^2 Ruvidar® (TLD-1433) Bladder infusion and Photodynamic TherapyExperimental Treatment1 Intervention
A single instillation of Ruvidar® (TLD-1433) (at the therapeutic dose of 0.7 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes. PDT treatment is performed after Ruvidar® (TLD-1433) has been rinsed from the bladder. Two Study Treatments will be performed, a primary Study Treatment at Day 0 and a maintenance Study Treatment at Day 180.
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Who is running the clinical trial?
Theralase Technologies Inc.Lead Sponsor
Theralase® Technologies Inc.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Theralase Inc.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or do not want to undergo major bladder surgery.I don't have any health issues that would interfere with the study.I am not on any treatments that are not allowed in this study.I am using two forms of birth control or am not having sex to join the study.I can hold my bladder for at least 60 minutes.I currently have an infection that needs treatment with medication.I cannot have general or spinal anesthesia due to health reasons.I am intolerant to BCG or it did not work for me despite receiving multiple doses.I have another cancer, but it's either not growing or is a type that doesn't need active treatment.My bladder cancer is confirmed high grade and not muscle-invasive.I am a woman who can have children and have a negative pregnancy test.I am a woman who can have children and have a negative pregnancy test.My bladder cancer is confirmed and graded with a recent test.I have a specific type of bladder cancer that has not spread beyond certain areas.I am over 18 years old.My bladder cancer has invaded the muscle layer or spread to other parts.I am currently experiencing visible blood in my urine.I haven't had bladder chemotherapy in the last month, except for a one-time dose right after bladder tumor surgery.I am able to care for myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: 0.7 mg/cm^2 Ruvidar® (TLD-1433) Bladder infusion and Photodynamic Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively seeking participants?
"Affirmative. The clinical trial is open for recruitment as indicated on the clinicaltrials.gov website, with a post date of August 30th 2019 and an update from May 6th 2022. A total of 100 individuals are needed at 11 distinct medical facilities."
Answered by AI
How many participants have enrolled in this clinical experiment?
"Affirmative, according to the clinicaltrials.gov listing this trial is recruiting participants as of today. This medical research was initially posted on August 30th 2019 and has been recently updated on May 6th 2022 with a goal of enrolling 100 subjects across 11 locations."
Answered by AI
How many sites are overseeing the administration of this clinical trial?
"11 trial sites have begun enrolling patients, including Virginia Urology in Richmond (Site 02009), University Health Network in Toronto (Site 01001) and The Vancouver Prostate Centre - Diamond Health Care Centre in Vancouver (Site 01005). Additionally, there are 8 other locations where enrolment is possible."
Answered by AI
Has the FDA granted its seal of approval to TLD-1433 Bladder infusion and Photodynamic Therapy?
"After taking into account the Phase 2 status of this medical trial, our team at Power assigned TLD-1433 Bladder infusion and Photodynamic Therapy a safety rating of 2 due to existing data confirming its security but no evidence yet affirming efficacy."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Site 02008 - MidLantic Urology
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Site 02008 - MidLantic Urology: < 48 hours
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