COG 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

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COG 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

1. To determine if treatment of infants with high risk PNET CNS tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell rescue results in a higher complete response rate than the same regimen without methotrexate
2. To determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors from primitive neuroectodermal tumors and possibly identifying other markers of value for stratification within the group of peripheral neuroectodermal
tumors.
3. To determine if event free survival and patterns of failure differ between the methotrexate arm and the arm without methotrexate.
4. To compare acute, chronic and late effects of different regimens
5. To compare quality of life outcomes

Protocol Number111110
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesBrain and Nervous System
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedCISPLATIN
METHOTREXATE
CYCLOPHOSPHAMIDE
ETOPOSIDE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.