Intravesical Photodynamic Therapy (PDT) in BCG Refractory High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
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|ClinicalTrials.gov Identifier: NCT03053635|
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG||Drug: TLD1433 infusion and photodynamic therapy (PDT) treatment||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients With Non-muscle Invasive Bladder Cancer at High Risk of Progression Who Are Refractory to Bacillus Calmette-Guerin Therapy and Who Are Medically Unfit for/Refuse Cystectomy|
|Actual Study Start Date :||December 21, 2016|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||March 30, 2019|
Experimental: 0.35 mg/cm^2 TLD1433 Bladder Dose
TLD1433 infusion and photodynamic therapy treatment (PDT):
TLD1433 is infused for 1 hour and photodynamic therapy treatment is performed after TLD1433 has been rinsed from the bladder. If treatment with the maximum recommended starting dose of 0.35mg/cm^2 does not raise significant safety concerns as determined by the safety monitoring committee, the therapeutic dose of TLD1433 (0.70mg/cm^2) will be used.
Drug: TLD1433 infusion and photodynamic therapy (PDT) treatment
TLD1433 is infused into the bladder, followed by repeated rinsing and treatment of bladder wall with photodynamic therapy (PDT).
Other Name: PDT
- Safety Analysis of TLD1433 and PDT assessed with the incidence and severity of Adverse Effects. [ Time Frame: Up to the completion of follow-up phase (180 days) ]Adverse events (AE) summaries will be provided showing the number and percentage of participants who experienced at least 1 AE. These summaries will be presented by body system and preferred term. Severe AEs (SAEs) and AEs resulting in discontinuation will be summarized separately in a similar fashion.
- Pharmacokinetic Analysis [ Time Frame: Blood (prior to drug, 1h, 4h, 8h, 24h, and 72h post drug). Urine (prior to drug, 8h, 24h, and 72h post drug) ]Pharmacokinetics (PK) parameters for blood and urine will be calculated using non-compartmental analysis. The Area Under the Curve (AUC0-t) will be calculated with the linear trapezoidal method.
- Exploratory Efficacy Analysis: The exploratory outcome endpoint is Recurrence-Free Survival (RFS). [ Time Frame: The overall efficacy will be evaluated during the course of the study (at 3 and 6 months) ]RFS is defined as the interval from Day 0 to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumor growth (i.e. any biopsy-confirmed new or recurrent tumor), evaluated at 90 days for the first three patients treated at the Maximum Recommended Starting Dose (MRSD) (0.35 mg/cm2) and primarily at 90 days for the last six patients treated at the Therapeutic Dose (0.70 mg/cm2) and secondarily one hundred and eighty (180) days post treatment. For patients who are lost to follow-up or withdraw from the study before recurrence or death, the RFS will be censored at last disease assessment (i.e.: date of last biopsy or cystoscopy); for participants who start new anti- cancer treatment (i.e.: chemotherapy, immunotherapy or radiotherapy) or undergo a cystectomy, the RFS will be censored at the last disease assessment (i.e.: date of last biopsy or cystoscopy) before the start of the new anti-cancer therapy or cystectomy.
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): NCT03053635
|Contact: Roger Dumoulin-White||416-699-5273 ext 225||RWhite@Theralase.com|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Michael Nesbitt|
|Principal Investigator:||Girish Kulkarni, MD, PhD||University Health Network, Toronto|