At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed medulloblastoma, supratentorial PNET (including variants), or ATRT
- ✓Age 3 to 21 years at diagnosis
- ✓Definitive CNS tumor surgery performed within 31 days
- ✓Average-risk disease: localized with no invasion beyond fossa/compartment; or T4 with gross total resection, residual <1.5 cm², and no CNS/extraneural metastasis
- ✕Prior chemotherapy
- ✕Prior radiotherapy
- ✕Pregnant or nursing
- ✕Hemoglobin ≤8 g/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
In Brief
A Phase 3 clinical trial evaluating filgrastim, cisplatin, and 4 other interventions for Brain and Central Nervous System Tumors. Completed, enrolled 416 participants across 9 sites in 3 countries.
Detailed Summary
Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE: * To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma. * To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).
Study Details
Timeline
Interventions
Given subcutaneously
Given IV
Given IV
Given IV
Patients undergo autologous stem cell transplantation
Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.