The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic of the Nasopharynx
研究概览
详细说明
To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Nasopharyngeal Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the nasopharyngeal cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the nasopharyngeal cancer patient using a similar protocol as investigators reported .
Aim 1: To demonstrate, in vitro, the relative cellular anti-nasopharyngeal cancer CSC immunity induced by nasopharyngeal cancer CSC-DC primed cytotoxic T cells.
Aim 2: To determine, in vitro, specific binding and lysis of nasopharyngeal cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with nasopharyngeal cancer CSC-DC.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510000
- Biological treatment center in Fuda cancer hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1.patients are greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease.
2.Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC).
3.serum creatinine of 2.0 mg/dl or less. 4.Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
5.WBC 3000/mm(3) or greater. 6.platelet count 90,000 mm(3) or greater. 7.serum AST/ALT less than three times normal. 8.ECOG performance status of 0 or 1. 9.Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.
10.Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy.
Exclusion Criteria:
1. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 2. level 3 hypertension; 3. severe coronary disease; 4. myelosuppression; 5. respiratory disease; 6. brain metastasis; 7. chronic infections
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:非癌干细胞疫苗
癌症干细胞疫苗的使用剂量、频率和持续时间仍未确定。
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实验性的:给予低剂量疫苗
癌症干细胞疫苗的使用剂量、频率和持续时间仍未确定。
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实验性的:给予中剂量疫苗
癌症干细胞疫苗的使用剂量、频率和持续时间仍未确定。
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实验性的:给予高剂量疫苗
癌症干细胞疫苗的使用剂量、频率和持续时间仍未确定。
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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主要研究目的是通过发生不良事件的参与者人数来确定使用癌症干细胞疫苗进行免疫接种的安全性
大体时间:长达 3 个月
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长达 3 个月
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次要结果测量
结果测量 |
大体时间 |
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次要目标是通过身体测量数据评估疫苗对免疫接种的免疫反应
大体时间:1个月
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1个月
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其他结果措施
结果测量 |
大体时间 |
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CSC疫苗的剂量
大体时间:长达 3 个月
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长达 3 个月
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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