EUCTR2012-004842-14-FR进行中（未招募）不适用
PHASE I / II STUDY OF SEQUENTIAL HIGH-DOSE CHEMOTHERAPY WITH STEM CELL SUPPORT IN CHILDREN YOUNGER THAN 5 YEARS OF AGE WITH HIGH-RISK MEDULLOBLASTOMA - HR MB-5
Institut de cancérologie Gustave Roussy0 个研究点开始时间: 2013年5月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Histological diagnosis of medulloblastoma with no INI-1 loss
- •- High risk medulloblastoma defined by at least one of the following conditions:
- •Newly diagnosed classical metastatic medulloblastoma
- •Newly diagnosed anaplastic/large cell medulloblastoma
- •Newly diagnosed medulloblastoma with amplification of c-myc or N-myc
- •- Age at initial biopsy less or equal than 5 years
- •- Weight compatible with leukapheresis
- •- Ability to comply with requirements for submission of materials for central review
- •- Nutritional and general status compatible with this therapy, Lansky play score = 30%
- •- Estimated life expectancy =3 months
- •- No organ toxicity other than neurological symptoms (grade >2 according to NCI-CTC v4.0 grading system)
- •- No prior irradiation or chemotherapy (except VP16 – CBP)
- •- Written informed consent from parents or legal guardian
- •Inclusion criteria for the Phase I part of the study:
- •- Complete response after intensification phase confirmed by central review
- •- Adequate hepatic and renal function
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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
- •- Desmoplastic medulloblastoma
- •- Atypical Teratoid rhabdoid tumour
- •- Uncontrolled active or symptomatic intracranial hypertension
- •- Patient incapable of undergoing medical follow-up
- •- Relapse of medulloblastoma
研究者
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