Phase I/II Study of URLC10-177 and TTK-567, Novel Tumor Specific Epitope Peptides Restricted to HLA-A*2402 Derived From Tumor Associated Antigens, Combined With CpG7909, a TLR9 Agonist, in Patients With Advanced or Recurrent Esophageal Cancer.
试验速览
- 阶段
- 1 期
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
研究概览
简要总结
This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patients with advanced or recurrent esophageal cancer.
详细描述
phase I: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (escalating doses: 0, 0.02, 0.1mg/kg) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, or for maximum 2 cycles, whichever occurs first. In this phase I study, we evaluate the safety and tolerability of URLC10-177, TTK-567 and different doses of CpG7909 to determine the recommended phase II dose of CpG7909.
phase II: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (recommended dose determined in phase I study) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered for 2 cycles. In this phase II study, we evaluate the efficacy of this vaccine therapy.
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 esophageal cancer precluding curative surgical resection and recurrent esophageal cancer
- •measurable disease by CT scan
- •PATIENT CHARACTERISTICS
- •ECOG performance status 0-1
- •Life expectancy > 3 months
- •Laboratory values as follows
- •2000/mm3 < WBC < 15000/mm3
- •Platelet count > 75000/mm3
- •Aspartate transaminase < 150 IU/L
- •Alanine transaminase < 150 IU/L
- •Creatinine < 2.0 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,radiation therapy, or immunotherapy within 4 weeks
- •Clinically significant heart disease
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
时间窗: 2 months
次要结局
- To analyze the toxicity(Phase II)(2months)
- To determine the clinical effectiveness in the patients with measurable disease(Phase I)(2months)
- survival(Phase II)(5 years)
- To evaluate immunological responses (Phase I/II)(2months)
- To determine the recommended phase II dose of CpG7909(Phase I)(2months)
- Time to progression(Phase II)(5 years)