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Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal
||ACNS0334, A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy without Methotrexate
Brain Tumors (Pediatric)
||Michael J. Kelly, MD
The overall goal of this study is to compare the effects, good and/or bad of induction therapy that includes methotrexate with induction therapy that does not include methotrexate on infants with high-risk medulloblastoma/PNET to find out which is better.
- Children less than 36 months (3 years) of age at time of definitive surgery who have high risk Medulloblastoma
- Children less than 36 months (3 years) of age at the time of definitive surgery with supratentorial PNET (any M-Stage)
- Children with anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor.
- Prior radiation therapy or chemotherapy other than corticosteroids
- Inadequate renal, liver, cardiac, pulmonary, and bone marrow functions
Participants will be randomized into two different regimens, A nd B.
Regimen A: Induction with vincristine, etoposide, cyclophosphamide, and cisplatin; with or without surgery; and consolidation with stem cell rescue
Regimen B: Induction with vincristine, etoposide, cyclophosphamide, cisplatin, and methotrexate; with or without surgery; and consolidation with stem cell rescue.Participants on this study will be followed up to ten years.
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