Carcinoma of Urinary Bladder, Invasive
Conditions
Keywords
Non Muscle Invasive Bladder Cancer, Carcinoma of urinary bladder, invasive, Intravesical instillation, Mitomycin C, Hydrogel, Reverse thermal gelation, Drug retention, radical cystectomy
Brief summary
The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
Detailed description
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.
Interventions
DEVICETC-3 gel
One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.
DEVICETC-3 gel mixed with Mitomycin C (MMC)
One intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter
Sponsors
UroGen Pharma Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form. * Patients with bladder cancer designated to undergo Radical Cystectomy
Exclusion criteria
* Sensitivity to MMC * Acute urinary Tract Infection (UTI) * Upper urinary tract obstruction. * Patient received neoadjuvant treatment previous to Radical Cystectomy * Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be pregnant * Breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation. | 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC. | 6 hours | Study participants undergoing bladder instillation with MMC mixed with TC-3 6 hours prior to radical cystectomy. Local (bladder) tissue levels of MMC will be evaluated and compared to MMC levels detected following treatment with MMC in saline (standard of cure). |
Countries
Israel
Outcome results
None listed