Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 or HLA-A*02 in Patients With Advanced Solid Tumors That Are Refractory to Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Evaluation of safety: the number of adverse events of vaccination therapy.
研究概览
简要总结
In this study, the investigators examine using a combination of two types of HLA-A*2402 (or HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
详细描述
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 or HLA-A*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.
In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402 or HLA-A*0201-positive advanced solid tumor patients who are refractory to standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
- •ECOG performance status 0-1
- •Age between 20 to 85
- •Clinical efficacy can be evaluated by some methods
- •No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
- •Life expectancy > 3 months
- •Laboratory values as follows 1500/mm3 < WBC < 10000/mm3 Platelet count > 75000/mm3 15% < Lymphcyte fraction Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value
- •HLA-A*2402 or HLA-A*0201
- •Able and willing to give valid written informed consent
排除标准
- •Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
- •Myocardial infarction within six months before entry
- •Breastfeeding and Pregnancy (woman of child bearing potential)
- •Active and uncontrolled infectious disease
- •Concurrent treatment with steroids or immunosuppressing agent
- •Other malignancy requiring treatment
- •Non-cured traumatic wound
- •Decision of unsuitableness by principal investigator or physician-in-charge
研究组 & 干预措施
HLA-A*2402 restricted peptides
HLA-A*2402 restricted peptides with adjuvant
干预措施: HLA-A*2402 or A*0201 restricted peptides (Biological)
HLA-A*0201 restricted peptides
HLA-A*0201 restricted peptides with adjuvant
干预措施: HLA-A*2402 or A*0201 restricted peptides (Biological)
结局指标
主要结局
Evaluation of safety: the number of adverse events of vaccination therapy.
时间窗: 2 months
Evaluation of clinical efficacy: Overall survival.
时间窗: 2 months
次要结局
- Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.(2 months)
- Evaluation of clinical efficacy: Progression free survival.(2 months)
- Evaluation of clinical efficacy: Tumor markers.(2 months)
- Evaluation of clinical efficacy: Objective response rate.(2 months)