Intravesical Photodynamic Therapy (PDT) in BCG Refractory/Intolerant Non-Muscle Invasive Bladder Cancer (NMIBC) Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03945162|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG||Combination Product: TLD-1433 Bladder infusion and Photodynamic Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Study of Intravesical Photodynamic Therapy in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Or Patients Who Are Intolerant to BCG Therapy ("Study").|
|Actual Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: 0.7 mg/cm^2 TLD-1433 Bladder infusion and Photodynamic Therapy
A single instillation of TLD-1433 (at the therapeutic dose of 0.7 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes. Photodynamic therapy treatment is performed after TLD1433 has been rinsed from the bladder. Two treatment procedures will be performed, a primary treatment at Day 0 and a secondary treatment at Day 180 post primary treatment.
Combination Product: TLD-1433 Bladder infusion and Photodynamic Therapy
TLD1433 is infused into the bladder, followed by repeated rinsing and treatment of bladder wall with photodynamic therapy (PDT).
Other Name: PDT
- Efficacy, evaluated by the Complete Response (CR) rate. [ Time Frame: Throughout the study and up to the completion of the follow-up phase (12 month) ]
The primary endpoint of this Study is efficacy, evaluated by the Complete Response ("CR") rate in patients with Carcinoma In-Situ ("CIS") with or without resected papillary disease at 360 days post primary treatment. CR is defined as at least one of the following:
- Negative cystoscopy and negative (including atypical) urine cytology.
- Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology.
- Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
For patients who are lost to follow-up or withdraw from the Study before recurrence or death, the CR will be censored at last disease assessment; for patients who start new anti- cancer treatment (i.e.: chemotherapy, immunotherapy or radiotherapy) or undergo a cystectomy, the CR will be censored at the last disease assessment before the start of the new anti-cancer therapy or cystectomy.
- Safety, evaluated by the incidence and severity of Adverse Events. [ Time Frame: Throughout the study and up to the completion of the follow-up phase (12 month) ]AE summaries will be provided showing the number and percentage of patients who experienced at least 1 AE. These summaries will be presented by body system and preferred term. AEs resulting in discontinuation will be summarized separately. Adverse Events (AEs) will be monitored from the time of signing the Informed Consent Form (ICF) until End of Study. The relationship of every AEs to the study drug will be determined and documented by the principal investigator whether considered treatment-related, and classified as related, unlikely, possibly, or probably related. All AEs should be treated appropriately. All AEs will be followed until resolution or stabilization or until End of Study (whichever comes first). The severity of each AE will be evaluated as mild, moderate, or severe.
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): NCT03945162
|Contact: Shawn Shirazi, Ph.D||416-699-5273 ext firstname.lastname@example.org|
|Contact: Arkady Mandel, MD, Ph.D.||416-699-5273 ext email@example.com|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada|
|Contact: Wendy Shoff|
|Principal Investigator: Joseph Chin, MD|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Michael Nesbitt|
|Principal Investigator: Girish Kulkarni, MD|
|McGill University Health Centre||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Raphael Freitas|
|Principal Investigator: Wassim Kassouf, MD|
|Principal Investigator:||Girish Kulkarni, MD, FRCSC||University Health Network, Toronto|