NCT02840123Unknown1 期
Phase Ib Clinical Trial on the Safety of Immunotherapy With Autologous Dendritic Cells Primed With Lysate Allogeneic Tumor Lines in Patients With Diffuse Intrinsic Pontine Glioma (DIPG)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of serious adverse events per patient (after treatment administration
研究概览
简要总结
The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines
Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed DIPG Patients without progressive disease
- •Aged between 3 and 18 yo Lansky scale >50 (Karnofsky for patients aged more than 16 yr)
- •Life expectancy > 8 weeks
- •Preserved bone marrow function Normal hepatic and renal function
排除标准
- •Impossibility to perform aphaeresis
- •Patient participation of other experimental study within the last 3 months
- •Patient under antitumor treatment in the last 4 weeks
- •Co-morbidity that does not allow the study treatment
- •Patients requiring > 2mg/day of dexamethasone treatment Corticoid-dependent patients
- •Patients under uncontrolled infection
- •Positive serologies of HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
研究组 & 干预措施
Autologous dendritic cells
Experimental
干预措施: Autologous dendritic cells (Biological)
结局指标
主要结局
Number of serious adverse events per patient (after treatment administration
时间窗: 2 years
次要结局
- Overall survival Progression free survival(1 year)
- Time to first Serious Adverse Event (SAE)(after treatment)(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A VaccinesHepatitis ANCT02601040Jiangsu Province Centers for Disease Control and Prevention13,500
终止
2 期
Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)Diffuse Intrinsic Pontine GliomaNCT01182350Karen D. Wright MD53
终止
1 期
Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine GliomasBrain CancerBrain Stem TumorsPontine TumorsNCT01058850Paul Graham Fisher3
已完成
3 期
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency DisordersPrimary Immunodeficiency Diseases (PID)Immune Thrombocytopenic Purpura (ITP)Kawasaki SyndromeNCT00157079Baxalta now part of Shire61
终止
1 期
Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With MelanomaMelanomaNCT00977145Craig L Slingluff, Jr11