A Phase I/IIa Study of Autologous Cell-based Vaccine Therapy With CreaVax-PC in Hormone-Refractory Metastatic Prostate Cancer Patients With PSA Relapse to Evaluate the Safety and Efficacy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- PSA increment and absolute PSA response
研究概览
简要总结
This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.
详细描述
CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens.
If patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (CreaVax-PC). In detail, patients will receive CreaVax-PC injection at intervals of 3 weeks, maximum 6 times during 21 weeks. PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. We also evaluate time to progression, overall survival and immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed prostatic carcinoma patient
- •Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed
- •Just 18 years over
- •Has a score ≤1 on the ECOG Performance Scale
- •Expected survival life time ≥ 6month
- •Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3
- •Adequate blood coagulation function PT(INR) < 1.5, aPTT< 1.5 x control
- •Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times
- •Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times
- •Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity
- •Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy
- •Patient who voluntarily participated clinical trial and confirmed a written consent
排除标准
- •Having other malignancy or previous history of malignancy
- •Brain metastases patient
- •Having autoimmune disease or its history
- •Pyrexia, rigor, leukocytosis infectious disease
- •HBsAg, anti-HCV, HIV positive patient
- •Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension
- •Severe and active medical disease
- •Mental history disease or epilepsy
- •Patients participated other clinical trial within 4 weeks
- •Patients impossible to participate this trial by investigator's decision
- •Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks
结局指标
主要结局
PSA increment and absolute PSA response
时间窗: 12 weeks
PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks
次要结局
- Time to Progression(DC Injection to time to progression or death)
- Overall Survival(Patients will be followed until death)
- Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)(weeks 0, 12, 21)
- Clinical response(week 0, 12, 21)