Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers
详细描述
KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression profile analysis by the use of cDNA microarray in the previous studies. The investigators have determined the HLA-A*2402 restricted epitope peptides respectively derived from KOC1, TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated with the appropriate targets expressing the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore the investigators focused on the prevention of further expansion of the solid tumors highly expressing these 5 proteins using these 5 peptides.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of unresectable or relapsed gastrointestinal, lung or cervical cancer patients
- •performance status 0-1
- •age between 20 and 80
- •at least 4 weeks after previous therapy
- •life expectancy more than 3 months
- •permissible bone marrow, liver and renal function
- •HLA-A2402
- •no viral hepatitis, HIV or HTLV1
排除标准
- •severe underlying disease
- •pregnant or lactating women
- •active brain metastasis
- •uncontrollable infection
- •under systemic corticosteroid or immune suppressant treatment
- •history of allergy to epitope peptides or IFA
结局指标
主要结局
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
时间窗: 2 years
次要结局
- immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail(2.5 years)