DRKS00002070进行中（未招募）1 期
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) - Mistletoe extract WEME 200 mg study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- WELEDA AG
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Age: 18 - 80 years.
- •2. Histologically confirmed superficial bladder carcinoma: pTa G2 or pT1 G1-2; re-resected tumours included.
- •3. No evidence of lymph node involvement and/or metastasis.
- •4. Transurethral R0-resection of the bladder tumour 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.
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 G1-grading.
- •2. Previous intravesical instillation therapy within the last 6 months.
- •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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