Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recurrence rate after surgery (TUR-BT)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt
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. The investigators 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 prevention of the recurrence of the bladder cancer after surgery using these 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
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Bladder cancer without solitary and low grade tumor
- •Protein expression of MPHOSPH1 and DEPDC1 on the tumor
- •PATIENTS CHARACTERISTICS
- •Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt.
- •Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder.
- •Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy
- •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
- •Samples 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
Recurrence rate after surgery (TUR-BT)
时间窗: 2 years
次要结局
- feasibility(2 years)
- CTL response(2 years)
- CD8 population(2 years)
- Change in level of regulatory T cells(2 years)
- Overall survival(5 years)