NCT00859729已完成1 期
DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients With Relapsed Prostate Cancer. A Phase I/II Study
Uppsala University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.
研究概览
简要总结
This study will assess the feasibility and safety of vaccination with increasing doses of xenogenic DNA administered intradermally in combination with electroporation in patients with relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine delivery system.
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
- •Male patients. Age >18 years.
- •HLA-A*0201 positive.
- •Histologically confirmed prostate cancer.
- •Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy.
- •Serum testosterone within normal range.
- •Increasing PSA from a previous reference value on two (2) consecutive occasions at least one month apart and with a minimum of 2 ng/mL above nadir.
- •PSA doubling time is one (1) year or less.
- •No evidence of metastatic prostate cancer.
- •Karnofsky performance status ≥
- •Adequate organ function:
- •AST and ALT ≤ 2.0 x upper limit of normal (ULN); total serum bilirubin ≤ 1.5 x ULN
- •Calcium ≤ 2.6 mmol/L, serum creatinine ≤ 1.5 x ULN
- •Hb ≥ 100 g/L; absolute leukocyte count ≥ 3.0 x 109 /L; platelets ≥100 x 109 /L
- •Life expectancy ≥ 12 months.
- •Swedish or English speaking subjects only.
- •Written informed consent (subjects must be capable of providing their own informed consent).
排除标准
- •Previous ablation of testis.
- •Radiologic evidence of metastatic disease.
- •Prior chemotherapy or investigational therapy/agents within 4 weeks.
- •Active bacterial, viral or fungal infection.
- •Carrier of HIV, HBV, or HCV.
- •Immunosuppressed (post splenectomy, post stem cell transplantation) or on immunosuppressive therapy other than inhaled or replacement corticosteroids.
- •Any other major illness or peripheral blood vein status that, in the investigator's judgement, will substantially increase the risk associated with sampling or participation in this study.
- •Subjects with cardiac demand pacemakers.
- •Any reason why, in the opinion of the investigator, the patient should not participate.
结局指标
主要结局
Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.
时间窗: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
次要结局
- Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.(From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination)
- Evaluate the PSA-specific immune response induced by the vaccine.(From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination)
- Identify an anti-tumor effect of the vaccine.(From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination)
研究者
Jeffrey Yachnin
Prinicple Investigator
Uppsala University
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients with Relapsed Prostate Cancer. A Phase I/II StudyPatients with relapse of prostate cancer.EUCTR2006-001128-38-SEppsala University Hospital18
进行中（未招募）
2 期
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate CancerProstate CancerNCT03600350University of Wisconsin, Madison19
已完成
1 期
Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected AdultsHIV InfectionNCT00249106International AIDS Vaccine Initiative45
终止
1 期
Safety Study of Recombinant Listeria Monocytogenes(Lm)Based Vaccine Virus Vaccine to Treat Oropharyngeal CancerHPV-16 +ve Oropharyngeal CarcinomaNCT01598792University of Liverpool2
已完成
1 期
A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSFProstate CancerNCT02411786University of Wisconsin, Madison40