At a glance
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A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma
In Brief
A Phase 1 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Autologous Hematopoietic Stem Cell Transplantation, and 17 other interventions for Ganglioneuroblastoma and 5 related conditions. Completed, enrolled 99 participants across 25 sites.
Detailed Summary
This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.
Study Details
Timeline
Interventions
Undergo radiotherapy
Undergo autologous in vitro-treated peripheral blood stem cell transplantation
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo radiotherapy
Undergo autologous in vitro-treated peripheral blood stem cell transplantation
Undergo radiotherapy
Given IV
Given PO
Correlative studies
Given IV
Correlative studies
Ancillary studies
Undergo surgery
Given IV
Given IV