(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

This is a randomized Phase III trial for children less than 36 months old with high-risk medulloblastoma/PNET. It is designed to determine whether the addition of high dose methotrexate to three cycles of the 4 drug induction backbone (Regimen B) will achieve a higher complete response rate versus three cycles of the 4 drug induction regimen itself (Regimen A). Both of these induction regimens will be followed by three tandem stem cell transplants using the maximum tolerated dose of thiotepa of 10mg/kg/day. After completion of 3 cycles of induction therapy, if complete response has not been attained, then a second surgical attempt at gross total resection is strongly encouraged, if feasible. Although radiation therapy is not a part of this clinical trial, guidelines for radiation therapy are included and the use of radiation therapy should be given serious consideration following the completion of resection.

Study Number: 

NCG 123707

Principal Investigator: 
ClinicalTrials.Gov ID: 

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.