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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TheraCoat Ltd.
ClinicalTrials.gov Identifier:
NCT01648010
First received: July 17, 2012
Last updated: May 6, 2013
Last verified: December 2012

July 17, 2012
May 6, 2013
November 2011
May 2013   (final data collection date for primary outcome measure)
Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01648010 on ClinicalTrials.gov Archive Site
Assessment of the levels of MMC in patients urinary bladder following intravesical instillation of TC-3 mixed with MMC. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
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).
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Carcinoma of Urinary Bladder, Invasive
  • Device: TC-3 gel
    One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.
  • 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
    Other Name: MMC Gel
  • Experimental: TC-3 gel
    TC-3 gel group undergo intravesical instillation of the investigatory device
    Intervention: Device: TC-3 gel
  • Experimental: MMC- gel
    MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC
    Intervention: Device: TC-3 gel mixed with Mitomycin C (MMC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01648010
TAS-4M-PR-H-127-1, HTA 5972
No
TheraCoat Ltd.
TheraCoat Ltd.
Not Provided
Study Director: Michal Jeshurun, MD TheraCoat Ltd.
TheraCoat Ltd.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP