.a.

Phase 1

• Conditions: Patients with primary treatment-naïve vesical neoplasms.; MedDRA version: 21.1Level: LLTClassification code 10046702Term: Urogenital neoplasmSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2021-003751-42-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-22
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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 < 2
- Multiple lesions with at least one lesion not smaller than 1 cm as diagnosed through cystoscopy
- Negative urinoculture at the beginning of neoadjuvant treatment
- Signed informed consent according to ICH/EU GCP, and national/local regulations. All patients have to provide written informed consent before study entry and all phases of this study will be in compliance with the Declaration of Helsinki.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified