Status:
COMPLETED
Intravesical Electromotive Mitomycin After Bacillus Calmette-Guérin Failure
Lead Sponsor:
University of Rome Tor Vergata
Collaborating Sponsors:
University of Bari
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 (...
Detailed Description
Partecipants Inclusion criteria: * Patients with urothelial high risk NMIBC (high grade stage Ta, T1 and/or carcinoma in situ) after intravesical BCG failure; * adequate bone marrow reserve; * norma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04311580
Start Date
January 1 2000
End Date
March 10 2020
Last Update
June 22 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.