Clinical trial
Intravesical Electromotive Mitomycin for High Risk Urothelial Non-muscle Invasive Bladder Cancer After Intravesical Bacillus Calmette-Guérin Failure
Name
UTV/08-05-95
Description
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.
Trial arms
Trial start
2000-01-01
Estimated PCD
2013-12-31
Trial end
2020-03-10
Status
Completed
Phase
Early phase I
Treatment
intravesical electromotive administration of mitomycin
Arms:
urothelial high risk non-muscle invasive bladder cancer
Size
52
Primary endpoint
Time to first recurrence
Up to 100 monthss. Time from enrollment to first cystoscopy noting disease recurrence.
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}
Updated at
2023-06-22
1 organization
1 product
1 indication
Organization
University of Rome Tor VergataProduct
MitomycinIndication
Bladder Cancer