What side effects are associated with this type of intervention?

Photodynamic therapy (PDT) for Non-Muscle Invasive Bladder Cancer (NMIBC), such as the use of Ruvidar® (TLD-1433), commonly causes localized pain, inflammation, and photosensitivity reactions. Other treatments like intravesical chemotherapy with mitomycin or gemcitabine can lead to chemical cystitis, rash, and, in rare cases, myelosuppression. These side effects are generally manageable but require monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Muscle Invasive Bladder Cancer (NMIBC), including Bacillus Calmette-Guerin (BCG) therapy and chemotherapeutic agents like mitomycin C. However, specific to photodynamic therapy (PDT), the FDA has approved the use of aminolevulinic acid (ALA) for PDT in treating actinic keratoses, which is a similar mechanism to the one being studied with Ruvidar® (TLD-1433) for NMIBC. ALA is a photosensitizer that, when activated by light, produces reactive oxygen species to kill cancer cells. This approval highlights the potential of PDT in treating various types of cancer, including NMIBC.

What other types of research exist?

Promising novel alternatives to Ruvidar® (TLD-1433) for NMIBC patients include: 1) Immune checkpoint inhibitors such as pembrolizumab, which have shown efficacy in treating BCG-unresponsive NMIBC. 2) Gene therapy approaches like nadofaragene firadenovec, which delivers a gene to the bladder cells to stimulate an immune response against cancer cells. 3) Targeted therapies such as enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, which is being explored for urothelial carcinoma. These alternatives offer different mechanisms of action and have shown potential in clinical studies.

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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

Must not have

Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications)

Have an active infection requiring systemic therapy, including active or intractable Urinary Tract Infection ("UTI"), not resolved prior to the procedure

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

No Placebo-Only Group

Summary

This trial tests a new treatment for bladder cancer patients who do not respond to or cannot tolerate standard therapy. The treatment uses a drug called Ruvidar® that is activated by a special light to kill cancer cells in the bladder.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on any treatments that are not allowed in this study.

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I currently have an infection that needs treatment with medication.

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I cannot have general or spinal anesthesia due to health reasons.

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I have a specific type of bladder cancer that has not spread beyond certain areas.

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My bladder cancer has invaded the muscle layer or spread to other parts.

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I am currently experiencing visible blood in my urine.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study ii and up to the completion of the follow-up phase (15 month) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy, evaluated by Complete Response ("CR").

Secondary study objectives

Efficacy, evaluated by the duration of CR

Other study objectives

Safety, evaluated by the incidence and severity of Adverse Events.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Muscle Invasive Bladder Cancer (NMIBC) include transurethral resection of bladder tumor (TURBT), intravesical therapy, and photodynamic therapy (PDT). TURBT involves physically removing the tumor from the bladder. Intravesical therapy, such as Bacillus Calmette-Guerin (BCG) or chemotherapy, involves instilling therapeutic agents directly into the bladder to kill cancer cells and prevent recurrence. Photodynamic therapy (PDT) uses a photosensitizing agent like Ruvidar® (TLD-1433) that, when activated by a specific wavelength of light, produces reactive oxygen species to destroy cancer cells. Understanding these mechanisms is crucial for NMIBC patients as it helps in selecting the most appropriate treatment, managing expectations, and improving adherence to therapy protocols.

Photodynamic therapy of bladder cancer cell lines.