EUCTR2005-003100-11-IT进行中（未招募）不适用
Phase III study on the effectiveness of OSAG 101 Theraloc in newly diagnosed intrinsic pontine gliomas of children and adolescents - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Newly diagnosed intrinsic pontine glioma documented in MRI and measurable in at least one dimension Age o 3 3 years to o 20 years, both gender Life expectancy o 4 weeks Performance status ECOG o 3 or Karnofsky/Lansky status o 40 Adequate hematological, renal, and hepatic function
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pontine glioma as secondary malignancy Low grade brain stem glioma i.e. focal, cervicomedullar, tectal brain stem glioma Other severe underlying disease or pre-existing serious conditions which bear the risk of an inadequate study treatment e.g. severe mental retardation, severe statomotoric retardation, severe cerebral palsy, congenital syndromes Prior antineoplastic therapy, inclusively chemotherapy, immunotherapy, radiotherapy Prior administration of a recombinant human or mural antibody or known hypersensitivity to antibodies Simultaneously other antineoplastic therapy than the study treatment Participation in another therapeutic study or experimental treatment involving the underlying cancer disease Pregnancy, lactating mother and inadequate contraception in females and males of childbearing age
研究者
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