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
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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 |
- 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.
- 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 |
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 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 June 18, 2013