Dose-Escalation-Study With abnobaVISCUM® Fraxini 2 (AVF2) as Intravesical Instillation in Patients With Superficial Bladder Cancer According to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) - Guidelines: a Phase Ib/IIa Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abnoba Gmbh
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation
研究概览
简要总结
The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.
详细描述
A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2 are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete TUR of all other lesions according a study design established by the EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion and by cytology. Safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. After treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
- •Written informed consent for study participation and for documentation of disease data including further distribution of these data
排除标准
- •Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
- •Intravesical instillation therapy within 6 months prior to study enrolment
- •Radiotherapy of the bladder prior to study enrolment
- •Contracted bladder (capacity less than 100 ml)
- •Non treated acute or chronic urinary tract infection
- •Allergy against mistletoe extract preparations
- •Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml)
- •Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse)
- •Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception
- •Participation in another clinical study within 30 days prior to this study
- •Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment
- •Chronic progressive infections (e. g. tuberculosis)
- •Pre-treatment with mistletoe extracts/mistletoe lectins
研究组 & 干预措施
Dose escalation
intravesical instillation of abnobaVISCUM Fraxini
干预措施: abnobaVISCUM Fraxini (Drug)
结局指标
主要结局
Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation
时间窗: 6 weeks
The primary objective is to investigate the maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation in patients with superficial bladder cancer. The treatment schedule included 6 weekly instillations.
次要结局
- Influence on remission and influence on the one year recurrence rate of abnobaVISCUM Fraxini for intravesical instillation(up to 1 year)
- Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation(6 weeks)