293
Participants
Start Date
December 17, 2007
Primary Completion Date
September 27, 2017
Study Completion Date
April 30, 2026
Induction Chemotherapy
All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.
Low-Risk Therapy
Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
High-Risk Therapy
High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
Intermediate-Risk Therapy
"Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).~Note: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan."
Lady Cilento Children's Hospital, Brisbane, Brisbane
St. Jude Children's Research Hospital, Memphis
Children's Hospitals and Clinics of Minnesota - St. Paul, Saint Paul
University of Texas Southwestern Medical Center at Dallas, Dallas
Rady Children's Hospital, San Diego
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto
University of Florida
OTHER
National Cancer Institute (NCI)
NIH
The Pew Charitable Trusts
OTHER
St. Jude Children's Research Hospital
OTHER