A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity and maximum tolerable dose.
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the immunological effects of this regimen in these patients.
- Determine the progression-free survival and clinical responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.
Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HLA-A*0201 positive adults over the age of
- •Have HCC with a serum AFP determination >30ng/ml.
- •Both male and female patients may be enrolled.
- •Karnofsky Performance Status greater than or equal to 70 percent.
- •No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
- •No previous evidence of opportunistic infection.
- •Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:
- •Hemoglobin >9.0g/dl
- •Platelets >50000/mm3
- •Absolute Neutrophil Count >1,000/mm3
- •Child-Pugh Class A or B for chronic liver disease.
- •Ability to give informed consent.
排除标准
- •Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
- •Concomitant steroid therapy or chemotherapy, or any of these other treatments < 30 days before the first vaccination.
- •Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).
- •Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
- •HIV-infected patients.
- •Patients with any underlying conditions which would contraindicate therapy with study treatment.
- •Patients with organ allografts.
- •O2 sat <91% on room air; dyspnea at rest.
结局指标
主要结局
Dose limiting toxicity and maximum tolerable dose.
时间窗: 1 year
次要结局
- Generation of AFP specific immunity.(3 years)
- Progression-free survival.(3 years)
- clinical response in patients with measurable disease.(3 years)