Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma
The phases of the study are:
1. Screening phase: Tests and evaluations will be done before treatment starts.
2. Induction phase: Includes chemotherapy plus hu14.18K322A mAb. Participants will also
have surgery during this part of the study to remove as much tumor as possible.
3. Consolidation/Intensification phase: Includes high doses of chemotherapy and blood stem
cell transplantation with additional, experimental "minimal residual disease" (MRD)
treatment.. Participants will also get radiation treatment to all sites of the tumor(s)
after recovery from the stem cell transplant.5. Maintenance/MRD treatment phase: With
immune therapy in addition to the standard treatment with the drug isotretinoin.
4. Maintenance/MRD treatment phase: With immune therapy in addition to the standard
treatment with the drug isotretinoin.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with complete or partial response
To study the efficacy [response: complete remission + partial remission (CR+PR)] to two initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4 doses/course followed by GM-CSF) in previously untreated children with high-risk neuroblastoma.
after two initial courses of chemotherapy (approximately 6 weeks after enrollment)
Wayne L. Furman, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
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