Clinical trial · Interventional

Intravesical Electromotive Mitomycin After Bacillus Calmette-Guérin Failure

Intravesical Electromotive Mitomycin for High Risk Urothelial Non-muscle Invasive Bladder Cancer After Intravesical Bacillus Calmette-Guérin Failure

NCT04311580CI-TRIAL-00067364completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
intravesical electromotive administration of mitomycin	Combination Product	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
urothelial high risk non-muscle invasive bladder cancer
description
patients with urothelial high risk non-muscle invasive bladder cancer after failed intravesical bacillus Calmette-Guérin treatment.
interventionNames
1. Combination Product: intravesical electromotive administration of mitomycin

Primary outcomes (1)

measure
Time to first recurrence
timeFrame
Up to 100 monthss. Time from enrollment to first cystoscopy noting disease recurrence.
description
Time from enrollment to first cystoscopy noting disease recurrence.

Secondary outcomes (1)

measure
Time to disease progression
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 90 Years

Show eligibility criteria text

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.

References

Publications (5)

RESULTDi 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
RESULTDi 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
RESULTDi 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
RESULTDi 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
RESULTDi 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