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
  Purpose

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.


Condition Intervention
Carcinoma of Urinary Bladder, Invasive
Device: TC-3 gel
Device: TC-3 gel mixed with Mitomycin C (MMC)

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

Resource links provided by NLM:


Further study details as provided by TheraCoat Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 7
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TC-3 gel
TC-3 gel group undergo intravesical instillation of the investigatory device
Device: TC-3 gel
One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.
Experimental: MMC- gel
MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC
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

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648010

Locations
Israel
Barzilai Hospital
Ashkelon, Israel
Wolfson
Holon, Israel
Beilinson
Petah-Tikva, Israel
Sponsors and Collaborators
TheraCoat Ltd.
Investigators
Study Director: Michal Jeshurun, MD TheraCoat Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: TheraCoat Ltd.
ClinicalTrials.gov Identifier: NCT01648010     History of Changes
Other Study ID Numbers: TAS-4M-PR-H-127-1, HTA 5972
Study First Received: July 17, 2012
Last Updated: May 6, 2013
Health Authority: Israel: Israeli Ministry of Health

Keywords provided by TheraCoat Ltd.:
Non Muscle Invasive Bladder Cancer
Carcinoma of urinary bladder, invasive
Intravesical instillation
Mitomycin C
Hydrogel
Reverse thermal gelation
Drug retention
radical cystectomy
Intravesical Instillation

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on July 29, 2014