EUCTR2009-013406-13-CZ进行中（未招募）不适用
First Line Therapy of Glioblastoma Multiforme with Surgical Resection, Irradiation Therapy, Temozolomide and Additional Tumour-Lysate Pulsed Dendritic Cell Vaccination. A Feasibility Phase II Study. - NA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •Female or male, aged between 18 and 70 years (at time of diagnosis)
- •Glioblastoma multiforme (WHO IV), proven by reference histology
- •Total, subtotal or partial resection of more than 70% of tumour mass defined by MRI
- •Tumour localisation: Brain or spinal cord, except diffuse intrinsic brain-stem glioma
- •Life expectancy of at least 12 weeks by assessment of the attending physician
- •Written informed consent of patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Positivity for blood transmitted diseases - HIV, HBV, HCV or syphilis.
- •Partial resection of less than 70% of tumour mass defined by MRI
- •Corticosteroid treatment necessary within five days before leukocyte apheresis
- •Diffuse brain-stem glioma
- •Insufficient amount of tumour tissue available for vaccine production
- •Anti-neoplastic chemotherapy or radiotherapy (brachy- or teletherapy) prior to enrollment
- •Poor clinical condition
- •Pregnancy or nursing
- •Evidence of an active infectious disease or active autoimmune disease
- •Participation on another therapeutic Phase I, II or III study at least 4 weeks before entering the study
研究者
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