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 : February 27, 2017
|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 :||December 1, 2017|
|Estimated Study Completion Date :||December 1, 2017|
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
- Assessment of Safety: Evaluation of the safety of TLD1433 will be assessed with the incidence and severity of Adverse Effects [ Time Frame: Up to the completion of follow-up phase (180 days) ]
Hematology, blood chemistry, and urinalysis for safety purposes will be performed at days 1, 3, 30, 60, 90 and 180 as well as at the time of premature discontinuation. Troponin testing will only be performed at day 1, 3, and 30.
CT scan will be performed at Day 30 and Day 180 to identify possible tissue reaction to PDT.
ECG will be performed at baseline, during the study treatment and Day 1 (24 hours) after study treatment. An additional ECG will be performed at 8 hours ± 15 minutes post-drug instillation to correspond with the 8 hour PK blood sample at Day 0.
Vital signs (blood pressure, heart rate, respiratory rate and temperature) will be recorded for safety purposes at every visit throughout treatment and at the end of study.
A comprehensive physical examination for safety purposes is required during Screening and at the Month 6/End of Study and End of Treatment.
Multiple measurements will be aggregated into number of abnormal results different from baseline for each subject.
- Pharmacokinetics of TLD1433 in blood and urine (Cmax) [ 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) of TLD1433 will be assessed with the maximum observed concentration (Cmax) in blood and urine.
- Pharmacokinetics of TLD1433 in blood and urine (area under curve) [ 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) of TLD1433 will be assessed with the area under the curve from time zero to the last quantifiable concentration (AUC0-t) in blood and urine.
- Efficacy: Recurrence is defined as the interval from Day 0 to documented recurrence [ Time Frame: The overall efficacy will be evaluated during the course of the study (at 3 and 6 months) ]
Recurrence is defined as any new tumour growth, i.e. any biopsy-confirmed new or recurrent tumour, or positive saline bladder washing cytology.
Recurrence endpoint is either:
- Recurrence-free survival rate at 3 and 6 months.
- Recurrence rate at 3 and 6 months.
- Efficacy: Survival is defined as the interval from Day 0 to documented survival or death of any cause. [ Time Frame: The overall survival will be evaluated during the course of the study (at 3 and 6 months) ]
Survival endpoints is either:
- Overall survival during the course of the study.
- Overall survival rate at 3 and 6 months.
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|