Patients after transurethral R0-resection (TUR) of a histologically confirmed superficial bladder carcinoma (pTa low grade [multilocular or recurrence], pT1 low grade)
Conditions
Interventions
Product Name: WEME 200 mg
Product Code: WEME 200 mg
Pharmaceutical Form: Solution for intravesical use
CAS Number: 8500009178
Current Sponsor code: WEME 200 mg
Other descriptive name: MISTLETOE EXTRAC
Sponsors
Verein fuer Krebsfoschung (Society for Cancer Research)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 80 years. 2. Histologically confirmed superficial bladder carcinoma: pTa low grade [multilocular or recurrence] or pT1 low grade; re-resected tumours included. 3. No evidence of lymph node involvement and/or metastasis. 4. Transurethral R0-resection of the bladder tumour and immediate instillation of mitomycin C (dosage and administration according to respective SmPC) within 2 - 7 weeks before inclusion into the study; re-resection of the tumour included. 5. Patient information according to applicable national legislation and international guidelines followed by signing and dating the informed consent form. 6. Female, pre-menopausal patients must provide negative pregnancy test within two weeks before study entry and are willing to apply a highly effective birth-control method. 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: 1. Bladder carcinomas with one or more of the following characteristics: Carcinoma in situ (pTis), pT2-4, N1-3, M1, G3-4; furthermore are excluded pTa-tumours with low grade-grading which are not multilocular or recurrent. 2. Previous intravesical instillation therapy within the last 6 months (except previous immediate instillation of mitomycin C at day of transurethral R0-resection). 2.b Secondary damage of previous administration of intravesical chemotherapy, e.g. necrosis of urothelium or stenoses. 3. Previous radiation therapy. 4. Bladder resection. 5. Contracted bladder with capacity 38 °C. 9. Other concomitant diseases likely to make participation of the patient difficult at the discretion of the investigator. 10. Clinically relevant cardiac arrhythmias. 11. Severe allergic illness (including asthma); known hypersensitivity to mistletoe products. 12. Any other current or planned oncological therapy (surgery, radiotherapy, chemotherapy, other mistletoe products including s.c. therapy with Iscador®). 13. Previous medical therapy that could interfere with the objectives of this study including mistletoe therapy within the last month. 14. Concomitant treatment with other immunomodulatory medications. 15. Known abuse of medicaments, alcohol or illegal drugs. 16.Laboratory parameters outside the following limits: Creatinine > 2x upper limit of normal Bilirubine > 3x upper limit of normal Transaminases > 3x upper limit of normal 17. Pregnancy or breast-feeding. 18. Pre-menopausal women not applying an effective birth control method. 19. Doubt concerning the compliance. 20. Previous participation in this clinical trial earlier in study course. Participation in any other clinical trial currently or within the last month. 21. Subjects which are in a state of dependence in relation to the sponsor’s or investigator’s institutions or which are their employees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the maximum tolerated dose (MTD) of a mistletoe-extract (oak) manufactured by WELEDA (WEME 200 mg) in intravesical instillation in the selected patient population, based on the incidence of dose-limiting toxicities (DLTs), to describe the optimal dose ranges for putative phase II/III trials.;Secondary Objective: 1. To investigate safety and tolerability of different dosages of intravesically applied mistletoe extract (WEME 200 mg). 2. To acquire first data about the clinical effects of intravesical instillation of WEME 200 mg in superficial bladder carcinoma. - To describe tumor recurrence rate 3, 6, 9 and 12 months after start of therapy.;Primary end point(s): Estimation of the MTD (i.e., the highest dose applied provoking a dose-limiting toxicity [DLT] at a probability of maximally 33%) by fitting an a priori set dose-toxicity-relationship model to the observed rate of DLTs according to a modified version of the ‚Continual Reassessment Method (CRM)’. | — |
Countries
Germany
Outcome results
None listed