MT2018-19: COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)
This partially randomized phase III trial studies iobenguane I-131 or ALK Inhibitor Therapy and standard therapy in treating younger patients (365 days to 30 years of age) with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.
• Age: Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
• Diagnosis: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
• The following disease groups are eligible: INRG Stage M & MYCN amplification or age > 547 days OR INRG Stage MS disease with MYCN amplification OR INRG Stage L2 disease with MYCN amplification
• Patients who have an INRG Stage L2 tumor without amplification of MYCN
• Patients with bone marrow failure syndromes
• Pregnancy and Breastfeeding
Procedure: Autologous Hematopoietic Stem Cell Transplantation, Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration and Biopsy, Drug: Busulfan, Drug: Carboplatin, Drug: Cisplatin, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Dexrazoxane Hydrochloride, Biological: Dinutuximab, Drug: Doxorubicin Hydrochloride, Procedure: Echocardiography Test, Drug: Etoposide Phosphate, Radiation: External Beam Radiation Therapy, Radiation: Iobenguane I-123, Radiation: Iobenguane I-131, Drug: Isotretinoin, Drug: Lorlatinib, Procedure: Magnetic Resonance Imaging, Drug: Melphalan Hydrochloride, Procedure: Multigated Acquisition Scan, Procedure: Positron Emission Tomography, Biological: Sargramostim, Procedure: Therapeutic Conventional Surgery, Drug: Thiotepa, Drug: Topotecan Hydrochloride, Drug: Vincristine Sulfate
Cancer
high risk, metastatic, neuroblastoma