NCT00891748已完成1 期
A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
Uppsala University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Toxicity
研究概览
简要总结
The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of transitional cell carcinoma of the bladder
- •18 years of age or older
- •signed informed consent
- •for the Phase I part: patient scheduled for cystectomy
排除标准
- •Woman of childbearing potential (fertile woman)
- •Other malignancy within 5 years of study, except for non-melanoma skin cancer
- •Metastatic disease
- •Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy.
- •Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study.
- •Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator.
- •Chronic urinary tract infections.
- •Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care.
- •Vesical capacity <150mL and/or vesical obstruction with residual >150 mL after spontaneous voiding.
- •Previous exposure to any experimental drug within 3 months from enrolment.
- •Any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures.
- •Patients who presently have urothelial cell carcinoma of the upper G.U. tract
- •Patients with systemic autoimmune disease
- •Patients that do not consent to that tissue and blood samples are stored in a biobank
- •Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment
结局指标
主要结局
Toxicity
时间窗: Continously during therapy and at follow up 30d
次要结局
- Inflammation(Continously during treatment and at follow up 30d)
研究者
研究点 (2)
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