Patients with primary treatment-naïve vesical neoplasms. MedDRA version: 21.1 Level: LLT Classification code 10046702 Term: Urogenital neoplasm System Organ Class: 100000004864
Conditions
Interventions
Product Name: MITOMICINA
Product Code: [n.a.]
Pharmaceutical Form:
INN or Proposed INN: MITOMICINA
Current Sponsor code: n.a.
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and females, age >18 years old - Primary “clinical” diagnosis of urinary bladder cancer and secondary recurrent untreated bladder cancer. The clinical diagnosis will be based on the combination of imaging (ultrasound, CT and MRI), flexible cystoscopy with NBI in out-patients regimen, and urine cytology assessment - Urine cytology negative or positive - Treatment naïve vesical neoplasm at time of enrollment - Eastern Cooperative Oncology Group (ECOG) performance status =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Known hypersensitivity to MMC or any of its constituents - Major surgery, other than diagnostic surgery - Previous or concomitant cancer of the upper urinary tract or the prostatic urethra - Previous (within the last 3 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri - Presence of significant urologic disease (urethral stricture or hypospadias) interfering with intravesical therapy - Pregnancy and breastfeeding status - Current enrolment or participation in another therapeutic clinical trial within 4 weeks preceding treatment start - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator - Treated with immunomodulatory agents (including cortisone treatment) at time of enrollment or in the two months before enrollment - Treated with antibiotics at time of enrollment or during the month before enrollment - Positive history of sexually transmitted diseases - Suffering from an ongoing or recent (during the three months before enrollment) urinary infection - Suffering from chronic intestinal inflammation Due to the genotoxic potential of mitomycin, it is suggested to a man looking for offspring, during treatment and up to 6 months later to stock the sperm before the start of therapy due to the possibility of irreversible infertility caused by therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this phase III clinical trial we will test the hypothesis that the neoadjuvant instillation of MMC in patients with vesical neoplasms induces the development of an antitumor response, which is effective in controlling tumor recurrence.;Secondary Objective: Secondary clinical endpoint: 1 Analysis of the rate of grade and stage progression in case of recurrence calculated after 3, 6, 12 and 24 months after TUR. 2 Correlation between clinical response and expression of the Mitomarker. Secondary biological endpoints: 1. Analysis of the ability of MMC to induce ICD by measuring in midstream urine samples HMGB1, a known alarmin molecule, and interleukin (IL)-1ß, an inflammatory cytokine, that are known to be secreted by tumor cells undergoing ICD (13). 2. Analysis of specific changes in the urinary microbiome composition and correlation with ICD induction and clinical response, by performing microbiome profiling following a protocol established in the Rescigno laboratory.;Primary end point(s): The primary endpoint of the study is to evaluate the efficacy of MMC neoadjuvant treatment in reducing the recurrence rate of vesical neoplasms. The success rate is measured as no recurrence and will be calculated as the proportion of patients who achieve a complete response following EAU guidelines (no evidence of cancer after 3, 6, 12 and 24 months after TUR).;Timepoint(s) of evaluation of this end point: The selected time points are the ones in which according to the normal clinical practice control cystoscopies are schedules. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary clinical endpoint: 1 Analysis of the rate of grade and stage progression in case of recurrence calculated after 3, 6, 12 and 24 months after TUR. 2 Correlation between clinical response and expression of the Mitomarker. Secondary biological endpoints: 1. Analysis of the ability of MMC to induce ICD by measuring in midstream urine samples HMGB1, a known alarmin molecule, and interleukin (IL)-1ß, an inflammatory cytokine, that are known to be secreted by tumor cells undergoing ICD (13). 2. Analysis of specific changes in the urinary microbiome composition and correlation with ICD induction and clinical response, by performing microbiome profiling following a protocol established in the Rescigno laboratory.;Timepoint(s) of evaluation of this end point: The selected time points are the ones in which according to the normal clinical practice control cystoscopies are schedules. | — |
Countries
Italy
Contacts
Public ContactU.O. di Urologia
IRCCS Istituto Clinico Humanitas
Outcome results
None listed