Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of Patients With Immunological Response
研究概览
简要总结
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC).
Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone.
The primary objective is to evaluate the vaccine specific immune response and patients will be evaluated with blood tests and DTH reactions during the treatment course.
Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.
详细描述
Treatment in details:
Dendritic cell (DC) vaccination The DC vaccine consists of adherent monocytes collected by leukapheresis. Monocytes are stimulated with GM-CSF and IL-4, and IL-1β, TNFα, IL-6 and PGE2 are used for further maturation.
DCs are transfected with PSA, PAP, survivin and hTERT mRNA. DC vaccines will only be given to patients in ARM A
Docetaxel:
Docetaxel will be given as an i.v. infusion every third week, 75 mg/m2 according to standard treatment. Patients will be pretreated with prednisolon before infusion with Docetaxel. Continuous treatment with prednisolon will not be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 verified CRMPC in progression, defined by
- •RECIST-criteria and/or
- •PSA increase to more than baseline in two consecutive measurements
- •Treatment with Docetaxel is indicated
- •Age > 18 years old
- •ECOG performance status ≤2
- •Life expectancy > 3 months
- •Normal organ function
排除标准
- •Other malignant tumors
- •Severe heard or lung disorders
- •Infection with HIV, hepatitis, tuberculosis.
- •Severe allergy or previous anaphylactic reactions
- •Active autoimmune disease
- •Treatment with immunosuppressive drugs (including prednisolon, methotrexate)
- •Co-treatment with other experimental treatments, other antineoplastic treatment.
研究组 & 干预措施
Arm A
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
干预措施: mRNA transfected dendritic cell (Biological)
Arm A
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
干预措施: Docetaxel (Drug)
Arm B
Docetaxel alone
干预措施: Docetaxel (Drug)
结局指标
主要结局
Number of Patients With Immunological Response
时间窗: 2 years
The induction of vaccine specific immune responses will be assessed using interferon-gamma ELISPOT assay
次要结局
- Number of Patients With PSA Response(2 years)
- Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine(2 years)
- Progression-free Survival(2 years)
研究者
Inge Marie Svane
Professor
Herlev Hospital