Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma

Launched by GUSTAVE ROUSSY, CANCER CAMPUS, GRAND PARIS · Dec 30, 2013

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Eligibility criteria

• Inclusion Criteria:
• • 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 or other unfavourable histology confirmed by review and coordinating investigator
• • 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-Common Toxicity Criteria v4.0 grading system)
• • No prior irradiation or chemotherapy (except Vepesid - CBP)
• • Written informed consent from parents or legal guardian
• • All patients must be affiliated to a social security regimen or be a beneficiary of the same in order to be included in the study.
• Inclusion criteria for the Phase I part of the study:
• • Complete response after intensification phase confirmed by central review
• • Adequate hepatic and renal function
• Exclusion Criteria:
• • Desmoplastic medulloblastoma
• • Atypical Teratoid rhabdoid tumour
• • Uncontrolled active or symptomatic intracranial hypertension
• • Patient incapable of undergoing medical follow-up
• • Relapse of medulloblastoma