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

NCT ID: NCT01648010

Last Updated: 2013-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

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.

Conditions

Carcinoma of Urinary Bladder, Invasive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

TC-3 gel

TC-3 gel group undergo intravesical instillation of the investigatory device

Group Type: EXPERIMENTAL

TC-3 gel

Intervention Type: DEVICE

One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.

MMC- gel

MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC

Group Type: EXPERIMENTAL

TC-3 gel mixed with Mitomycin C (MMC)

Intervention Type: DEVICE

One intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter

Interventions

TC-3 gel

One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.

Intervention Type: DEVICE

TC-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

Intervention Type: DEVICE

Other Intervention Names

MMC Gel

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UroGen Pharma Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michal Jeshurun, MD

Role: STUDY_DIRECTOR

UroGen Pharma Ltd.

Locations

Barzilai Hospital

Ashkelon, , Israel

Wolfson

Holon, , Israel

Beilinson

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

HTA 5972

Identifier Type: OTHER

Identifier Source: secondary_id

TAS-4M-PR-H-127-1

Identifier Type: -

Identifier Source: org_study_id