NCT01498172已完成1 期
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
研究概览
简要总结
In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient with histological confirmation of NMIBC
- •Full recovery from surgery (TUR) from 1 to 6 weeks
- •Karnofsky performance status of 60% or more
- •Laboratory parameters for vital functions should be in the normal range
- •Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration
- •Male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment
排除标准
- •Muscle invasive bladder cancer
- •Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available
- •Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
- •Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial)
- •History of severe allergic reactions to vaccines or unknown allergens
- •Patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
- •The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted
- •Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
- •Lack of availability for immunological and clinical follow-up assessment
- •For female patients of childbearing potential: positive urine or serum pregnancy test or lactating
- •Known positive HIV test, HBV, HCV.
结局指标
主要结局
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
时间窗: 6 months
次要结局
- Flow cytometric analysis of type and number of immune cell types in urine(6 months)
- Measurement of titers of antibodies against recMAGE-A3 in serum(6 months)
- Assessment of disease recurrence by control cystoscopy(6 months)
研究者
Patrice Jichlinski
Chief of Urology Department
University of Lausanne Hospitals
研究点 (2)
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