Intravesical Photodynamic Therapy (PDT) in BCG Refractory High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
Status:
Completed
Trial end date:
2018-08-09
Target enrollment:
Participant gender:
Summary
This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects
with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy
will be eligible for participation in the study. Bacillus Calmette-Guerin (BCG) intolerance
or refractory disease are defined as inability to tolerate or failure to achieve a
tumour-free state after at least one induction (a minimum of 5 instillations) followed by
either a second induction (a minimum of 5 instillations) or at least 2 maintenance
instillations. Subjects experiencing disease relapse within 12 months or less after finishing
the second course of BCG therapy are also considered refractory. The study will consist of 2
phases. In the first phase, 3 subjects will receive PDT (TLC-3200 System) employing 0.35
mg/cm^2 (maximum recommended starting dose) TLD1433. If treatment with the maximum
recommended starting dose does not raise significant safety concerns as determined by the
safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm^2
(therapeutic dose) TLD1433.
Phase:
Phase 1
Details
Lead Sponsor:
Theralase Inc.
Collaborators:
Medelis Inc. University Health Network, Toronto WCCT Global