PDT for Bladder Cancer
Recruiting in Palo Alto (17 mi)
+21 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Theralase Technologies Inc.
Disqualifiers: Muscle invasive cancer, Metastatic cancer, Active hematuria, Active infection, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you cannot be on any prohibited therapies. It's best to discuss your current medications with the study team to see if they are allowed.
What data supports the effectiveness of the treatment Ruvidar® (TLD-1433) for bladder cancer?
A study showed that photodynamic therapy (PDT) using TLD-1433 was tested in patients with bladder cancer that did not respond to previous treatments, suggesting it may be effective for this condition.
12345Is photodynamic therapy (PDT) for bladder cancer safe?
Research shows that photodynamic therapy (PDT) for bladder cancer, including treatments using TLD-1433 and other photosensitizers, is generally safe. Studies have reported no serious treatment-related side effects, and any bladder irritation or volume loss was related to the light dose and tumor extent, but not severe.
23456What makes the treatment Ruvidar® (TLD-1433) unique for bladder cancer?
Ruvidar® (TLD-1433) is unique because it uses photodynamic therapy (PDT), which involves a special drug activated by light to destroy cancer cells, specifically for patients whose bladder cancer does not respond to standard Bacillus Calmette-Guérin (BCG) treatment.
23457Eligibility Criteria
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.Inclusion Criteria
I cannot or do not want to undergo major bladder surgery.
Be willing and able to provide a written Informed Consent Form ("ICF") for the Study
Are available for the duration of the Study including follow-up (approximately 15 months)
+9 more
Exclusion Criteria
Is pregnant or breastfeeding within the projected duration of Study II, starting with the screening visit through to two weeks following the second Ruvidar® (TLD-1433) instillation
Participated in a study with an investigational agent or device within 1 month from the first dose of current Study treatment
I don't have any health issues that would interfere with the study.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
6 weeks
Primary Treatment
Participants receive the first intravesical PDT treatment with Ruvidar® (TLD-1433) at Day 0
1 day
1 visit (in-person)
Maintenance Treatment
Participants receive the second intravesical PDT treatment with Ruvidar® (TLD-1433) at Day 180
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
15 months
Multiple visits at Day 0, 7, 30, 60, 90, 180, 187, 210, 240, 270, 360, and 450
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Site 02-006 - Carolina Urologic Research CenterMyrtle Beach, SC
Site 02-011 - University of Wisconsin Health University HospitalMadison, WI
Site 01-001 - University Health Network - Princess Margaret Cancer CentreToronto, Canada
Site 02-007 - Urology Associates, P. CNashville, TN
More Trial Locations
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Who Is Running the Clinical Trial?
Theralase Technologies Inc.Lead Sponsor
Theralase® Technologies Inc.Lead Sponsor
Theralase Inc.Lead Sponsor
University Health Network, TorontoCollaborator
Pharma eMarketCollaborator
References
Efficacy and safety of photodynamic therapy for recurrent, high grade nonmuscle invasive bladder cancer refractory or intolerant to bacille Calmette-Guérin immunotherapy. [2022]We evaluated the effectiveness of photodynamic therapy using Radachlorin in patients with high grade, nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Guérin therapy who refused radical cystectomy.
Photodynamic therapy of bladder cancer - a phase I study using hexaminolevulinate (HAL). [2013]To assess the safety and feasibility of hexaminolevulinate (HAL) based photodynamic therapy (PDT) as adjuvant treatment after transurethral resection of the bladder (TURB) in patients with intermediate or high-risk urothelial cell carcinoma (UCC) of the bladder.
Green light photodynamic therapy in the human bladder. [2007]We conducted this pilot clinical study to investigate the safety, primarily acute toxicity, of green light (514.5 nm) whole bladder photodynamic therapy (PDT) in human bladders with transitional cell carcinoma. We enrolled five patients who were scheduled to undergo radical cystectomy and urinary diversion for locally muscle invasive bladder cancer. Four patients received intravenous injection of Photofrin at 1 mg/kg, while one patient received no drug, 48 hr before undergoing green light whole bladder photoactivation with light doses of 20-60 J/cm 2. Each patient underwent radical cystectomy on day 7 following light treatment. Post-PDT evaluation included daily monitoring of voiding symptoms, cystometric measurements of bladder capacity, and gross and histopathologic examination of the excised bladders. Our results show that the intensity of acute bladder irritation and acute post-PDT loss in bladder volume depended on the light dose and extent of bladder tumor with the associated inflammation. There was no transmural bladder injury and no treatment related morbidity. These data on acute toxicity suggest that green light whole bladder PDT treatment with 1 mg/kg of Photofrin and 20-40 J/cm 2 of laser power is safe.
A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer. [2022]A phase 1b study of photosensitizer TLD-1433-mediated photodynamic therapy (PDT) was performed in bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) patients.
Photodynamic diagnosis in patients with T1G3 bladder cancer: influence on recurrence rate. [2021]Therapeutic strategies on treatment of T1G3 urothelial cancer of the urinary bladder are controversial. The objective of this study was to investigate the impact of photodynamic diagnosis (PDD) on the recurrence-free survival rate of patients with the initial diagnosis of T1G3 bladder cancer.
Transurethral Resection of Non-Muscle Invasive Bladder Tumors Combined with Fluorescence Diagnosis and Photodynamic Therapy with Chlorin e6-Type Photosensitizers. [2023]Bladder cancer is a common disease with a high recurrence rate. In order to improve the treatment of superficial bladder tumors, we evaluated the efficacy and safety of transurethral resection (TURB) followed by fluorescence diagnosis (FD) and photodynamic therapy (PDT) with chlorin e6 photosensitizers (PSs), viz. "Fotoran e6" and "Fotoditazin". It was found that both PSs generated singlet oxygen and revealed moderate affinity toward the lipid-like compartment. Between November 2018 and October 2020, 12 patients with verified non-muscle invasive bladder cancer (NMIBC) were treated by TURB combined with FD and PDT. Eight patients received "Fotoran e6" intravenously, while four patients received intravesical PSs. The patient ages were between 31 and 79 years, with a median age of 64.5 years (mean 61.3 ± 14.2). The total light dose was 150 J/cm2 for the local irradiation of the tumor bed with a red light at the λ = 660 nm wavelength, and 10-25 J/cm2 were additionally delivered for diffuse irradiation of the entire bladder mucosa. At the median follow-up period of 24 months (mean 24.5 ± 5.4 months, range 16-35 months), 11 patients remained tumor-free. One 79-year-old patient developed a recurrence without progression to the muscle layer. This pilot study shows that the TURB + FD + PDT technique is an effective and safe option for the first-line treatment of superficial bladder tumors.
The effect of photodynamic therapy on rat urinary bladder with orthotopic urothelial carcinoma. [2019]To assess the effect of whole-bladder photodynamic therapy (PDT) on a rat model with orthotopic superficial bladder cancer, as PDT is an alternative intravesical therapy for treating superficial bladder cancer, based on an interaction between a photosensitizer and light energy to induce oxygen radicals that destroy tissue by lipid peroxidation.