EUCTR2010-018447-34-GB进行中(未招募)1 期
Investigation of dendritic cell vaccine immunotherapy in paediatric high grade glioma - DC vaccine trial
Great Ormond Street Hospital for Children NHS Trust0 个研究点目标入组 20 人开始时间: 2011年8月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Histologically confirmed high-grade glioma (including anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma and anaplastic variants of ganglioglioma and pleomorphic xanthoastrocytoma)
- •Substantial debulking surgery (primary treatment or relapse group) or small volume recurrence (relapse group).
- •Available tumour lysate for DC pulsing
- •Informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Brain stem glioma
- •Metastatic spinal disease
- •Uncorrected hydrocephalus
- •Other ongoing chemotherapy
- •Positive serology for HIV, Hepatitis B or C, or positive TPHA test (syphilis)
- •Auto-immune disease (presence of autoantibodies in standard screen plus clinical features consistent with presence of antibodies)
- •Lansky/Karnovsky score less than 40 unless lower due to surgery
- •Pregnancy
- •Grade 4 CTC toxicity in any of the following categories
- •o Infection
- •o Dermatology/skin
- •o Gastrointestinal (excluding anorexia)
- •o Neurological (excluding sensory and audiological)
研究者
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