Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC
Conditions
Carcinoma of Urinary Bladder, Superficial
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Non Muscle Invasive Bladder Cancer, Intravesical instillation, Mitomycin C, Hydrogel Reverse thermal gelation, Drug retention, Intravesical Instillation, Urinary Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Diseases, Urologic Diseases, Mitomycin
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 40 mg MMC gel Type: Device
Name: Standard of care MMC mixed with water Type: Other
Name: 80 mg MMC gel Type: Device
Overall Status
Recruiting
Summary
In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode

The investigators believe that this study is of importance of several aspects:

1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.

2. If proved effective this mode of treatment might save the need of TURBT performance and serve as a new mode of tumor ablation.

3. Even if proved partially effective this mode of treatment will diminish tumors size or number thus enable a more limited TURBT procedure.

4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT, which might improve the patient's prognostic outcome.

5. If this experimental treatment will prove to have a better ablative effect, this could be translated to a better prophylactic effect of tumor recurrence.
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) or BCG. 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 biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug 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 instillation using TheraCoat gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.

Treatment Protocol - Immediately following baseline cystoscopy and tumor diagnosis and patient undergoes 6 weekly instillations followed by 2-4 weeks healing period.

1st Follow-Up Visit (Pre-Scheduled TURBT Visit): The patient will undergo a second Cystoscopy to compare to the Baseline status and after that a follow-up period: 3,6,9,12 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
Criteria: Inclusion Criteria:

- Single or multiple tumors (n≤7)

- Recurrent tumor.

- No prior history of HG and/or T1 and/or Tis

- At least one Tumor ≥ 1mm.

- Largest tumor diameter ≤ 30mm

- Cystoscopic appearance of papillary Low grade tumor

- The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis,Renal Cell Carcinoma or other renal cancers.

- Good performance status (Karnofsky performance status 70% or greater).

Exclusion Criteria:

- Sensitivity to MMC

- Acute urinary Tract Infection(UTI)

- Upper urinary tract obstruction.

- Treatment with intravesical chemotherapy within the 3 last months

- Cystoscopic Appearance suspicious for HG and/or solid and/or Tis

- The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening.

- Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be --pregnant

- Brest feeding women
Locations
Carmel Medical Center of Haifa, Department of Urology
Haifa, Israel
Status: Recruiting
Contact: Boris Friedman, MD
Wolfson Medical Center of Holon, Department of Urology
Holon, Israel
Status: Recruiting
Contact: Ami Sidi, Prof
Meir medical center
Kfar Saba, Israel
Status: Recruiting
Contact: Ilan Leibovitch, Prof - leibovitchi@clalit.org.il
Galil Maaravi Medical Center of Nahariya, Department of Urology
Nahariya, Israel
Status: Recruiting
Contact: Dov Engelstein, MD
Rabin Medical Center of Petah Tikva, Department of Urology
Petach Tikvah, Israel
Status: Recruiting
Contact: Daniel Kedar, MD
University hospital of Florence
Florence, Italy
Status: Recruiting
Contact: Alberto Lapini, MD - +393386622330 - lapinial@gmail.com
Vita Salute University, San Raffaele Hospital of Milan, Department of Urology
Milan, Italy
Status: Active, not recruiting
S. Andrea Hospital of Rome, Department of Urology
Rome, Italy
Status: Recruiting
Contact: A Tubaro, Prof
Fundacio Puigvert
Barcelona, Spain
Status: Recruiting
Contact: Juan Palou Redorta, MD/PhD
Hospital Universitario Infanta Sofìa of Madrid, Department of Urology
Madrid, Spain
Status: Recruiting
Contact: L Martinez-Piñeiro, Prof
Hôpital HUG of Geneva, Department of Urology
Geneva, Switzerland
Status: Recruiting
Contact: Gregory Wirth, MD
Start Date
June 2013
Completion Date
April 2016
Sponsors
TheraCoat Ltd.
Source
TheraCoat Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page