An Open Label Study Evaluating Short Term Safety and Tolerability of Patients With MUSCLE INVASIVE BLADDER CANCER- for Intravesical Instillation Mitomycin c Mixed With Disposable Device Which Prevents Drug Drainage Out of the Patient's Bladder
Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral
Resection - TUR), followed by series of intravesical instillations of prophylactic
chemotherapeutic drugs as Mitomycin C (MMC).This treatment approach is limited due to rapid
dilution the chemotheraputic drug by the incoming urine and clearance by urination.
TheraCoat core technology is based on a reverse thermal (low viscosity at 5°C) degradable
gel (TC-3)for MMC retention in the urinary bladder.
Prior to instillation, the TC-3 hydrogel,in a liquid state, is mixed with MMC.TC-3 mixed
with MMC is instilled to the bladder by a catheter.Following gel insertion to the bladder,
the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine
the gel dissolves and is cleared out from the bladder.
Intravesical MMC using TheraCoat gel is expected to increase treatment efficiency due to
prolongation of treatment duration and consequently improving bladder exposure to MMC.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.
Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. During these six hours the MMC levels in urine and blood will be measured every hour and the Peak Plasma Concentration (Cmax)and Area under the plasma concentration versus time curve (AUC) will be calculated and compared to the standard toxicity level in patients treated with MMC in saline (standard of cure). In addition, patient tolerability to treatment will be evaluated.
Michal Jeshurun, MD
Israel: Israeli Ministry of Health