Clinical trial NCT01648010: Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma of Urinary Bladder, Invasive
Keywords: Non Muscle Invasive Bladder Cancer
Carcinoma of urinary bladder, invasive
Intravesical instillation
Mitomycin C
Hydrogel
Reverse thermal gelation
Drug retention
radical cystectomy
Lead sponsor: UroGen Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 7
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.
timeFrame: 6 hours
Secondary outcomes:
measure: Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Hospital
city: Holon
country: Israel
facility: Wolfson
city: Petah-Tikva
country: Israel
facility: Beilinson
Study officials:
affiliation: UroGen Pharma Ltd.
name: Michal Jeshurun, MD
role: STUDY_DIRECTOR
References: