Title
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)

Description
Phase 3 Multi-modal Therapy for Neuroblastoma

Objective
The purpose of this research study is to see if we can improve the treatment for subjects with high-risk neuroblastoma (NBL) by adding
the experimental drug 131I-MIBG or the experimental drug Crizotinib to COG (Children s Oncology Group) recommended therapy. In this part of the study, we want to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation

Treatment Arm A treatment COG recommended therapy (not experimental)

Arm B treatment COG recommended therapy + 131I-MIBG during
Induction (experimental)

Arm C treatment COG recommended therapy + 131I-MIBG during
Induction and single stem cell transplant with BuMel (Busulfan and Melphalan) during Consolidation (experimental)

Key Eligibility
Both boys and girls of all races and ethnic groups are eligible for this study

Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531

Patient must be ≥ 365 days and ≤ 30 years of age

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

Adequate renal, liver and cardiac function

Ability to tolerate PBSC Collection

Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)

Can not have bone marrow failure syndromes

Can not be pregnancy or breast feeding

Sexually active patients of reproductive potential must agree to use an effective contraceptive method

Applicable Disease Sites
Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health University Hospital