NCT01266720Unknown1 期
Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 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 purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.
详细描述
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.
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
- •locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
- •Measurable disease by CT scan
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •laboratory values as follows: 2,000/mm3 < WBC < 15,000/mm3, Platelet count >75,000/mm3, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
- •HLA-A*0201
- •Able and willing to give valid written infromed 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 study
Experimental
Interventions:
Biological: VEGFR1, VEGFR2 Drug: Gemcitabine
干预措施: VEGFR1, VEGFR2 (Biological)
Phase 1 study
Experimental
Interventions:
Biological: VEGFR1, VEGFR2 Drug: Gemcitabine
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
- Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration(3 months)
- CD8 population(3 months)
- Change in level of regulatory T cells(3 months)
- Feasibility(1 year)
- Survival(1 year)
- Objective response rate(1 year)
研究者
研究点 (1)
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