Phase I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety(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, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.
详细描述
Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.
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
- •PATIENT CHARACTERISTICS
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •Laboratory values as follows
- •2000/mm3 < WBC < 15000/mm3
- •Platelet count > 75000/mm3
- •Bilirubin < 3.0 mg/dl
- •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(woman of childbearing potential:Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Active or uncontrolled infection
- •Concurrent treatment with steroids or immunosuppressing agent
- •Prior chemotherapy of gemcitabine
- •Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
- •Serious or nonhealing wound, ulcer, or bone fracture
- •Active or uncontrolled other malignancy
- •Interstitial pneumonia
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
Safety(toxicities as assessed by NCI CTCAE version 3)
时间窗: 3 months
次要结局
- survival(1 years)
- VEGFR2 peptide specific CTL induction in vitro(3 months)
- DTH to VEGFR2 peptide(3 months)
- Changes in levels of regulatory T cells(3 months)
- Objective response rate as assessed by RECIST criteria(1 year)
- Time to progression(1 years)