120
Participants
Start Date
December 20, 2022
Primary Completion Date
July 31, 2035
Study Completion Date
July 31, 2035
Surgical resection
"All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a second-look surgery may be performed between cycles of chemotherapy after discussion with the principal investigator."
Ommaya/VPS
All participants enrolled on S-1 will undergo
Methotrexate
Route of administration: Intravenously (IV)
Cisplatin
Route of administration: Intravenously (IV)
Vincristine
Route of administration: Intravenously (IV)
Cyclophosphamide
Route of administration: Intravenously (IV)
Carboplatin
Route of administration: Intravenously (IV)
Topotecan
Route of administration: Intravenously (IV)
Etoposide
Route of administration: Intravenously (IV)
Pegfilgrastim
Route of administration: subcutaneous (SQ)
Filgrastim
Route of administration: subcutaneous (SQ) or Intravenously (IV)
Irradiation
All participants in stratum N will undergo craniospinal irradiation (CSI) with boost to the primary tumor site once they reach 36 months of age. The dose given is based on the molecular risk group and disease response to chemotherapy as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.
Educational and Media Intervention
Participants watch a 75-minute caregiver education video program and receive access to interactive games on a smartphone or tablet throughout the optional cognitive study.
SOC, Educational and Media Intervention
Standard-of-care (SOC) treatment during main cognitive study. After the one-year serial cognitive evaluation, participants will be offered participation in the cognitive study group I intervention.
RECRUITING
Orlando Health Arnold Palmer Hospital for Children, Orlando
RECRUITING
St. Joseph's Children's Hospital, Tampa
RECRUITING
St. Jude Children's Research Hospital, Memphis
RECRUITING
C.S. MOTT Children's Hospital, University of Michigan, Ann Arbor
RECRUITING
Children's Hospital and Clinics of Minnesota, Minneapolis
RECRUITING
UT Southwestern/Simmons Cancer Center, Dallas
RECRUITING
Cook Children's Medical Center, Fort Worth
RECRUITING
Texas Children's Hospital, Houston
RECRUITING
Primary Children's Hospital, Salt Lake City
RECRUITING
Lucille Packard Children's Hospital at Stanford University, Palo Alto
National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER