Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer
2009年11月18日 更新者:Tokyo University
Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Esophageal Cancer
The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.
研究概览
详细说明
URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique.
In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in human esophageal tumors.
We identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro and vivo.
According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.
Patients will be vaccinated twice a week for 8 weeks.
On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first.
In the phase I study, we evaluate the safety and tolerability of these peptide vaccines.
In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.
研究类型
介入性
注册 (预期的)
14
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Tokyo
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4-6-1, Shirokanedai, Minato-ku、Tokyo、日本、108-8639
- The Institutute of Medical Science, University of Tokyo
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Advanced or recurrent esophageal cancer
- Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
- ECOG performance status 0-2
- Life expectancy > 3 months
- HLA-A*2402
- Laboratory values as follows 2000/mm3<WBC<15000/mm3 Platelet count>100000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L Creatinine < 3.0mg/dl
- Able and willing to give valid written informed consent
Exclusion Criteria:
- Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
- Uncontrolled brain and/or intraspinal metastasis
- Decision of unsuitableness by principal investigator or physician-in-charge
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:一个
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Patients will be vaccinated twice a week for 8 weeks.
On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
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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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Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
大体时间:Two months
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Two months
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次要结果测量
结果测量 |
大体时间 |
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To evaluate immunological responses
大体时间:Two months
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Two months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Naohide Yamashita, MD/PhD、The Institutute of Medical Science, University of Tokyo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8. doi: 10.1038/sj.onc.1205518.
- Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.
- Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
- Okabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年5月1日
初级完成 (实际的)
2009年4月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2008年5月19日
首先提交符合 QC 标准的
2008年5月19日
首次发布 (估计)
2008年5月21日
研究记录更新
最后更新发布 (估计)
2009年11月19日
上次提交的符合 QC 标准的更新
2009年11月18日
最后验证
2009年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
URC10, TTK, KOC1的临床试验
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Kyushu UniversityHuman Genome Center, Institute of Medical Science, University of Tokyo完全的
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Teikyo UniversityHuman Genome Center, Institute of Medical Science, University of Tokyo未知
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University of YamanashiHuman Genome Center, Institute of Medical Science, University of Tokyo未知
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Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of Tokyo完全的
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Wakayama Medical UniversityHuman Genome Center, Institute of Medical Science, University of Tokyo未知
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Fukushima Medical UniversityHuman Genome Center, Institute of Medical Science, University of Tokyo完全的
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Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of Tokyo终止