Phase Ｉ/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- toxicities as assessed by NCI-CACAE ver3)
研究概览
简要总结
The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine
详细描述
Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine
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
- •Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
- •Measurable disease by CT scan
- •PATIENTS CHARACTERISTICS
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •Laboratory values as follows:
- •2,000/mm3 < WBC < 15000/mm3
- •Platelet count ≥ 750,000/mm³
- •Total Bilirubin ≤ 1.5 x
- •Aspartate transaminase < 150 IU/L
- •Alanine transaminase < 150 IU/L
- •Creatinine ≤ 3.0 mg/dl
- •HLA-A*2402
- •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)
- •Breast-feeder
- •Active or uncontrolled infection
- •Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
- •Serious or uncured wound
- •Active or uncontrolled other malignancy
- •Steroids or immunosuppressing agent dependent status
- •Interstitial pneumonia
- •Decision of unsuitableness by principal investigator or physician-in-charge
研究组 & 干预措施
Phase 1/2 study
干预措施: VEGFR1-1084, VEGFR2-169 (Biological)
Phase 1/2 study
干预措施: Gemcitabine (Drug)
结局指标
主要结局
toxicities as assessed by NCI-CACAE ver3)
时间窗: 3 months
次要结局
- Objective response rate(1year)
- feasibility(1year)
- Survival(1year)
- Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration(3months)
- CD8 population(3months)
- Change in level of regulatory T cells(3months)
研究者
Takashi Kimura
Assistant professor
Fukushima Medical University