At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, and 10 other interventions for Anaplastic Medulloblastoma and 3 related conditions. Completed, enrolled 91 participants across 145 sites in 4 countries.
Detailed Summary
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.
Study Details
Timeline
Interventions
Undergo autologous PBSC resuce
Given IV
Given IV
Given IV
Given IV
Given IV or SC
Correlative studies
Given IV or orally
Given IV
Ancillary studies
Given IV
Given IV