Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

Completed · Phase 3

Conditions studied: Brain and Central Nervous System Tumors

In brief

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).

Key facts

Study ID

NCT00085202

Run by

St. Jude Children's Research Hospital

People needed

416

Starts

2003-08-01

Expected to finish

2023-12-31

Last updated by the study team

2024-02-08

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Duke Comprehensive Cancer Center — Durham, North Carolina, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital — Houston, Texas, United States
• Sydney Children's Hospital — Randwick, New South Wales, Australia
• Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Lady Cilento Children's Hospital, Brisbane — Brisbane, Queensland, Australia
• Royal Children's Hospital — Parkville, Victoria, Australia
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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