NCT01149902Unknown1 期
Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The safety and feasibility of chemo-immunotherapy
研究概览
简要总结
The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with relapsed and refractory head and neck squamous cell carcinoma
- •20 years and older
- •ECOG performance status 0-1
- •More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
- •Tumor lesions are accessible to intratumoral dendritic cells injection
- •Patients who are able to do oral ingestion
- •Patients must have normal organ and marrow functions as follows:
- •Hb>9.0 mg/dl
- •WBC>4000/mm3
- •Platelet count>100,000/mm3
- •T-Bil<1.5mg/dl
- •GOT<x2.5 institutional upper limit of normal
- •GPT<x2.5 institutional upper limit of normal
- •Creatinin<1.5mg/dl
- •signed informed consent
排除标准
- •Less than 20 years
- •Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
- •Patients with clinically active infection
- •Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
- •Concomitant malignant diseases, brain metastases
- •Psychiatric illness
- •Treatment with steroids
- •Decision of unsuitableness by physician
结局指标
主要结局
The safety and feasibility of chemo-immunotherapy
时间窗: 1 year
次要结局
- The number and function of immune effector cells in treated patients(1 year)
研究者
研究点 (2)
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