Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma (NCT02176967)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients must be:
2. \< 12 months (\< 365 days) of age at diagnosis with INRG stage L1; or
3. \< 18 months (\< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma
4. Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients
5. Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology \[ICD-O\] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology
6. Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index
7. "Favorable" genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index \> 1) in the absence of segmental chromosome aberrations as defined above
8. "Unfavorable" genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)
9. Only patients with MYCN non-amplified tumors are eligible for this study
10. Group A: patients \< 12 months (\< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
11. Greatest tumor diameter \< 5 cm of adrenal or non-adrenal origin
12. Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (222 Sites)

• Children's Hospital of Alabama — Birmingham, Alabama
• USA Health Strada Patient Care Center — Mobile, Alabama
• Providence Alaska Medical Center — Anchorage, Alaska
• Banner Children's at Desert — Mesa, Arizona
• Phoenix Childrens Hospital — Phoenix, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• Kaiser Permanente Downey Medical Center — Downey, California
• City of Hope Comprehensive Cancer Center — Duarte, California
• Loma Linda University Medical Center — Loma Linda, California
• Miller Children's and Women's Hospital Long Beach — Long Beach, California
• Children's Hospital Los Angeles — Los Angeles, California
• Cedars-Sinai Medical Center — Los Angeles, California
• Valley Children's Hospital — Madera, California
• UCSF Benioff Children's Hospital Oakland — Oakland, California
• Kaiser Permanente-Oakland — Oakland, California
• Children's Hospital of Orange County — Orange, California
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California
• Sutter Medical Center Sacramento — Sacramento, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• Rady Children's Hospital - San Diego — San Diego, California
• Naval Medical Center -San Diego — San Diego, California
• UCSF Medical Center-Mission Bay — San Francisco, California
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
• Children's Hospital Colorado — Aurora, Colorado

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.