E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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)
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The study is designed to evaluate the efficacy by analysing the recurrence free survival at six month. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The study is designed to evaluate the safety and severity of acute side effects of the treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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If more than 20 % of those patients receiving 1/10th dose BCG (lowest dose) have serious adverse events (SAE) (Common Toxicity Criteria v 3.0 ) grade III-IV the study will end. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |