Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients With Small Cell Lung Cancer Refractory to Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 restricted epitope peptides CDCA1 and KIF20A emulsified with Montanide ISA 51 for advanced small cell lung cancers.
详细描述
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from two cancer-testis antigens, CDCA1 and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed 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
- •SCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
- •ECOG performance status 0-2
- •Age between 20 to 85
- •Clinical efficacy can be evaluated by some methods
- •No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
- •Life expectancy > 3 months
- •Laboratory values as follows 1500/mm3 < WBC < 15000/mm3 Platelet count > 75000/mm3 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
- •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
CDCA1-KIF20A-1mg
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted CDCA1 peptide (1mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
干预措施: HLA-A*2402-restricted CDCA1 and KIF20A peptides (Biological)
CDCA1-KIF20A-2mg
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted CDCA1 peptide (2mg) and KIF20A peptide(2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
干预措施: HLA-A*2402-restricted CDCA1 and KIF20A peptides (Biological)
CDCA1-KIF20A-3mg
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted CDCA1 peptide (3mg) and KIF20A peptide(3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
干预措施: HLA-A*2402-restricted CDCA1 and KIF20A peptides (Biological)
结局指标
主要结局
Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.
时间窗: 2 months
Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.
时间窗: 2 months
次要结局
- Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.(2 months (every time point(s) at which each course is completed))
- Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.(2 months (every time point(s) at which each course is completed))
研究者
Yataro Daigo
Professor, Director of Cancer Center
Shiga University