Intravesical Electromotive Mitomycin After Bacillus Calmette-Guérin Failure

NCT04311580 | Completed Phase 2

• 1 other identifier: UTV/08-05-95
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

non-muscle invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to disease progression

  Up to 100 months. Time from randomisation until the onset of muscle invasive disease

Other Outcomes (1)

• Overall survival, and disease-specific survival

  Up to 100 months. Time from enrolment until death from any cause; disease specific survival as time from enrollment until death from bladder cancer

Study Arms (1)

urothelial high risk non-muscle invasive bladder cancer

EXPERIMENTAL

patients with urothelial high risk non-muscle invasive bladder cancer after failed intravesical bacillus Calmette-Guérin treatment.

Combination Product: intravesical electromotive administration of mitomycin

Interventions

intravesical electromotive administration of mitomycin COMBINATION_PRODUCT

urothelial high risk non-muscle invasive bladder cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead
• University of Bari: collaborator

Related Publications (5)

• 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.

  PMID: 9041189 RESULT

• 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.

  PMID: 10519404 RESULT

• 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;170(3):777-82. doi: 10.1097/01.ju.0000080568.91703.18.

  PMID: 12913696 RESULT

• 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 controlled trial. Lancet Oncol. 2006 Jan;7(1):43-51. doi: 10.1016/S1470-2045(05)70472-1.

  PMID: 16389183 RESULT

• 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 bladder cancer: a randomised controlled trial. Lancet Oncol. 2011 Sep;12(9):871-9. doi: 10.1016/S1470-2045(11)70190-5. Epub 2011 Aug 8.

  PMID: 21831711 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• SAVINO M DI STASI

  TOR VERGATA UNIVERSITY OF ROME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF UROLOGY

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: January 1, 2000
• Primary Completion: December 31, 2013
• Study Completion: March 10, 2020
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2024. Data will become available and for 24 months
• Access Criteria: Anyone who wishes to access the data.