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

Carcinoma of Urinary Bladder, Invasive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648010
• Other study ID #: TAS-4M-PR-H-127-1
• Secondary ID: HTA 5972
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: May 6, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2012
• Source: UroGen Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma of Urinary Bladder, Invasive
• Urinary Bladder Neoplasms

Intervention

Device:
• TC-3 gel
One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.
• 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

Locations

Country	Name	City	State
Israel	Barzilai Hospital	Ashkelon
Israel	Wolfson	Holon
Israel	Beilinson	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
UroGen Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hours	Yes
Secondary	Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC.	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).	6 hours	Yes

External Links

•   TheraCoat Ltd. is a medical application company developing biodegradable drug delivery systems for retention of chemotherapy intravesical instillation for Bladder Cancer.