Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- feasibility (toxicities as assessed by NCI-CTCAE version 3)
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide vaccination for advanced prostate cancer
详细描述
Cell division cycle associated gene 1(CDCA1) has been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. We have determined the HLA-A*2402 restricted epitope peptides derived from CDCA1, CDCA1-A24-56. This epitope showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A*2402. Furthermore, when vaccinated this peptide, specific CTL was determined after the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the advanced prostate cancer patients who already showed resistance to standard hormonal therapy and chemotherapy.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS advanced prostate cancer which already showed resistance to standard treatments
- •PATIENTS CHARACTERISTICS
- •Patients who showed resistance to hormonal therapy and chemotherapy
- •Histological diagnosis is adenocarcinoma
- •HLA-A*2402
- •ECOG performance status of 0 to 2
- •Age ≥ 20 years, ≤85 years
- •WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg
- •life expectancy ≥ 2months
- •Able and willing to give valid written informed consent
排除标准
- •Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
- •Serious infections requiring antibiotics
- •Concomitant treatment with steroids or immunosuppressing agent
- •Other malignancy difficult to control.
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
feasibility (toxicities as assessed by NCI-CTCAE version 3)
时间窗: 2 years
次要结局
- objective response rate as assessed by RECIST criteria(2 years)
- measurement of PSA(2 years)
- CTL response(2 years)
- CD 8 population(2 years)
- change in level of regulatory T cells(2 years)
- PFS and OS(2 years)