Bladder Cancer Clinical Trial
Official title:
Intravesical Electromotive Mitomycin for High Risk Urothelial Non-muscle Invasive Bladder Cancer After Intravesical Bacillus Calmette-Guérin Failure
Verified date | June 2023 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with urothelial high risk non-muscle invasive bladder cancer patients will be treated with intravesical electromotive drug administration/mitomycin (EMDA/MMC) after bacillus Calmette-Guerin (BCG) failure. Patients are scheduled for an initial 6 weekly treatments, a further 6 weekly treatments for non-responders and a followup 10 monthly treatments for responders. Complete response will be defined as histological disappearance of malignancy on bladder biopsy and resolution of abnormal cytological findings after treatment. Time to first recurrence, time to progression, overall survival, and disease-specific survival wil be estimated by use of the Kaplan-Meier method.
Status | Completed |
Enrollment | 52 |
Est. completion date | March 10, 2020 |
Est. primary completion date | December 31, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients with urothelial high risk non-muscle invasive bladder cancer (high grade stage Ta, T1 and/or carcinoma in situ) after intravesical BCG failure; - adequate bone marrow reserve; - normal renal function; - normal liver function; - Karnofsky performance score of 50 to 100; Exclusion Criteria: - Non-urothelial carcinomas of the bladder; - known allergy to mitomicyn ; - previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both; - bladder capacity less than 200 mL; - untreated urinary-tract infection; severe systemic infection (ie, sepsis); - urethral strictures that would prevent endoscopic procedures and catheterisation; - other concurrent chemotherapy, radiotherapy, and treatment with biological response modifiers; - other malignant diseases within 5 years of start of EMDA MMC (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer); - pregnancy; - psychological, familial, sociological, or geographical factors that would preclude study participation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata | University of Bari |
Di Stasi SM, Giannantoni A, Giurioli A, Valenti M, Zampa G, Storti L, Attisani F, De Carolis A, Capelli G, Vespasiani G, Stephen RL. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised control — View Citation
Di Stasi SM, Giannantoni A, Massoud R, Dolci S, Navarra P, Vespasiani G, Stephen RL. Electromotive versus passive diffusion of mitomycin C into human bladder wall: concentration-depth profiles studies. Cancer Res. 1999 Oct 1;59(19):4912-8. — View Citation
Di Stasi SM, Giannantoni A, Stephen RL, Capelli G, Navarra P, Massoud R, Vespasiani G. Intravesical electromotive mitomycin C versus passive transport mitomycin C for high risk superficial bladder cancer: a prospective randomized study. J Urol. 2003 Sep;1 — View Citation
Di Stasi SM, Valenti M, Verri C, Liberati E, Giurioli A, Leprini G, Masedu F, Ricci AR, Micali F, Vespasiani G. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bla — View Citation
Di Stasi SM, Vespasiani G, Giannantoni A, Massoud R, Dolci S, Micali F. Electromotive delivery of mitomycin C into human bladder wall. Cancer Res. 1997 Mar 1;57(5):875-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall survival, and disease-specific survival | Time from enrolment until death from any cause; disease specific survival as time from enrollment until death from bladder cancer | Up to 100 months. Time from enrolment until death from any cause; disease specific survival as time from enrollment until death from bladder cancer | |
Primary | Time to first recurrence | Time from enrollment to first cystoscopy noting disease recurrence. | Up to 100 monthss. Time from enrollment to first cystoscopy noting disease recurrence. | |
Secondary | Time to disease progression | Time from randomisation until the onset of muscle invasive disease | Up to 100 months. Time from randomisation until the onset of muscle invasive disease |
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