EUCTR2008-000782-35-DE进行中（未招募）不适用
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
Verein fuer Krebsfoschung (Society for Cancer Research)0 个研究点开始时间: 2009年1月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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