Status:
Completed
Clinicaltrials.gov identifier:
Sponsor:
Theralase Technologies Inc.
Enrollment:
57
Study Design:
This is a phase II, open-label, single-arm, multi-center study conducted in Canada, the United States and internationally. Patients with NMIBC CIS with or without resected papillary disease (Ta, T1) that are considered bacillus Calmette-Guerin (BCG)-Unresponsive or who are intolerant to BCG therapy are included. The patients are treated with two photodynamic therapy treatments with TLD-1433 (a photosensitizer that specifically targets transferrin) at 0 and 180 days upon enrollment. The photosensitizer is instilled in the bladder and then activated with an intravesical laser. The interim results of the trial are reported at this meeting.
Rationale:
This study evaluates a novel targeted form of photodynamic therapy in patients with BCG unresponsive CIS with or without papillary disease. The photosensitizer is instilled in the bladder and then activated by an intravesical laser.
Endpoints:
The primary endpoint is complete response (CR) rate and the main secondary endpoint is duration of CR.
Comments:
Photodynamic therapy has been proven to be effective in the past but was often plagued by side effects. The SAEs seen on this trial were not deemed to be due to the therapy and the historical concerns of bladder damage and sunlight sensitivity seen with older photodynamic therapy agents were not seen in this interim trial.
Results:
The primary outcome was a 54% CR rate at any time. However, of the 12 patients who were evaluated at 450 days, 67% had a CR. There were 9 serious adverse events (SAEs) but none were deemed to be due to the photodynamic therapy
