Trial Summary
What is the purpose of this trial?
This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.
Research Team
Jonathan Finlay, MD
Principal Investigator
Global Neuro-Oncology, Inc.
Girish Dhall, MD
Principal Investigator
Children's of Alabama at UAB
Randal Olshefski, MD
Principal Investigator
Nationwide Children's Hospital
Eligibility Criteria
This trial is for children under 10 years old with high-risk medulloblastoma or other CNS embryonal tumors. They must not have had previous radiation or chemotherapy, except corticosteroids, and should have adequate organ function. Children over 10, with certain excluded diagnoses like AT/RT or ependymomas, are not eligible.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Induction (Chemotherapy)
- Single Cycle Intensive Chemotherapy (Chemotherapy)
- Tandem 3 Cycle Intensive Chemotherapy (Chemotherapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Parth Patel
Lead Sponsor
Nationwide Children's Hospital
Lead Sponsor
Catherine Krawczeski
Nationwide Children's Hospital
Chief Medical Officer
MD
Timothy C. Robinson
Nationwide Children's Hospital
Chief Executive Officer since 2019
BSc in Psychology and Business Administration from Indiana University
Children's of Alabama
Collaborator