Dose-escalating study to determine the maximum tolerated dose (MTD) of the mistletoe extract WEME 200 mg for intravesical instillation in patients with completely resected (R0) superficial bladder carcinoma (pTa low grade [multilocular or recurrence], pT1 low grade) - Intravesical instillation of mistletoe extract (WEME 200 mg) in superficial bladder carcinoma

• Conditions: Patients after transurethral R0-resection (TUR) of a histologically confirmed superficial bladder carcinoma (pTa low grade [multilocular or recurrence], pT1 low grade); re-resections included.; MedDRA version: 9.1Level: LLTClassification code 10046518Term: Urinary bladder carcinoma

• Registration Number: EUCTR2008-000782-35-DE
• Lead Sponsor: Verein fuer Krebsfoschung (Society for Cancer Research)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-27
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 < 100 ml.
6. Inadequately treated acute or chronic urinary tracts infections.
7. Secondary neoplasia.
8. Co-morbidity with one of the following: active tuberculosis, active thyroid hyperfunction, known secondary cancer, HIV-infection/ AIDS, other severe systemic diseases as cardiac insufficiency, parasitosis or Crohn’s disease, acute inflammatory diseases with body temperature > 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.

Study & Design

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