Patients with intermediate/high risk non-muscle invasive bladder cancer (NMIBC) • intermediate risk tumours – Ta, T1 Grade 1, Grade 2, multifocal and tumours larger than 3 cm • high risk tumours – T1, Grade 3, multifocal or highly recurrent tumours and all cases of CIS (Carcinoma in situ) MedDRA version: 14.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Mitomycine C 20 mg
Product Name: Mitomycine C
Pharmaceutical Form: Solution for intravesical use
CAS Number: 0
Other descriptive name: MITOMYCIN C
Concentration unit: mg milligram(s)
Conce
Sponsors
Centre Hospitalier de Jolimont-Lobbes-Tubize-Nivelles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with intermediate/high risk NMIBC • intermediate risk tumours – Ta, T1 Grade 1, Grade 2, multifocal and tumours larger than 3 cm • high risk tumours – T1, Grade 3, multifocal or highly recurrent tumours and all cases of CIS (Carcinoma in situ) WHO performance status 0 to 2 and 18 years = age = 80 years 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of a bladder cancer type other than transitional cell carcinoma. Previous pelvic radiotherapy or systemic chemotherapy Residual urine > 150cc measured by ultrasound Urethral bleeding or persistent hematuria Known allergy to MMC Known impaired immune response, positive HIV serology, patients receiving systemic steroids or immunosuppressive therapy WHO performance status 3 to 4 and age = 81 years. Clinical presence or previous history of regional spreading or distant metastases Expected difficulties in the follow-up related to other diseases or too large distance between the patients home and the investigators centre. Polymorphonuclear (PMN) below 1.500/mm3 and/or platelet count below 100.000/mm3 before the treatment. Renal and hepatic function values may not exceed two times the upper normal value of the local laboratory. Uncontrollable urinary tract infection Patients with transitional cell carcinoma in the prostatic urethra, or in the upper urinary tract. Patients with active tuberculosis Pregnancy and lactation Patients with a previous (less than 5 years) or concurrent second primary carcinoma except for basal cell skin carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this trial is to evaluate the toxicity for intermediate and high risk NMIBC, after complete transurethral resection of all papillary tumours, of an intravesical sequential treatment combining MMC (mitomycine c) 40mg and BCG (Bacillus Calmette-Guérin) 1/10th , 1/6th and 1/4 dose. MMC will act as an apoptosis inductor and BCG as a recruiter of immune effectors, among which DCs. We then hope to obtain, in addition to the classical response to MMC, an immune response with a presentation of TAA in association with MHC class I able to induce a specific CTL-mediated response directed against the tumour. The study is designed to evaluate the safety and severity of acute side effects of the treatment.;Secondary Objective: The study is designed to evaluate the efficacy by analysing the recurrence free survival at six month.;Primary end point(s): The study is designed to evaluate the safety and severity of acute side effects of the treatment. | — |
Countries
Belgium
Outcome results
None listed