A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer. - Novel chemo-immunotherapy for non-muscle invasive bladder cancer
- Conditions
- 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: 14.1Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2011-000607-41-BE
- Lead Sponsor
- Centre Hospitalier de Jolimont-Lobbes-Tubize-Nivelles
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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.
- Secondary Outcome Measures
Name Time Method