Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 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 vaccination for advanced bladder cancer.
详细描述
DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have 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 DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.
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
- •DISEASE CHARACTERISTICS
- •advanced bladder cancer which already showed resistance to standard treatments
- •Protein expression of MPHOSPH1 and DEPDC1 on the tumor
- •PATIENTS CHARACTERISTICS
- •Patients who showed resistance to standard chemotherapies or radiotherapy
- •Histological diagnosis is transitional cell carcinoma
- •HLA-A*2402
- •ECOG performance status of 0 to 1
- •Age ≥ 20 years, ≤80 years
- •WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl
- •lesion of bladder cancer must express MPHOSPH1 or DEPDC1
- •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: 3 years
次要结局
- survival(3 years)
- CTL response(3 years)
- CD8 population(3 years)
- Change in level of regulatory T cells(3 years)
- objective response rate as assessed by RECIST criteria(3 years)