DRKS00013248招募中2 期
Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma - GlioVax
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV) confirmed by central neuropathology review
- •Near-complete resection (= 5 ml residual tumor volume) confirmed by central neuroradiologist on magnetic resonance imaging (MRI) scan within 72 h postoperative
- •Karnofsky performance status (KPS) = 70%
- •Sterile tumor sample of = 150 mg with tumor cell frequency = 60% as determined by central neuropathologist available for vaccine production
- •Successful production of sterile, avital tumor lysate
- •Systemic corticosteroids tapered down to = 2 mg of dexa-methasone or equivalent per day within 7 days postoperative
- •Adequate hepatic, liver and bone marrow function and blood coagulation
- •Signed informed consent
排除标准
- •Medical history of severe acute or chronic disease with poor prognosis, autoimmune disorder, immunodeficiency or organ allograft
- •Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or Trepo-nema pallidum or other severe infection requiring treatment
- •Known allergy or intolerability to components of vaccine, to TMZ or to dacarbazine
- •History of bleeding diathesis or coagulopathy
- •O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status equivocal
研究者
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