This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.
Eligibility
Sex
ALL
Min age
—
Max age
18 Months
Healthy volunteers
No
Inclusion Criteria:
* Patients must be:
* \< 12 months (\< 365 days) of age at diagnosis with INRG stage L1; or
* \< 18 months (\< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma
* Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients
* 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
* 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
* "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
* "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)
* Only patients with MYCN non-amplified tumors are eligible for this study
* Group A: patients \< 12 months (\< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
* Greatest tumor diameter \< 5 cm of adrenal or non-adrenal origin
* 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
* No prior tumor resection or biopsy
* Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes
* Group A1:
* \> 6 months and \< 12 months of age with an adrenal primary tumor \< 5 cm in greatest diameter OR
* Patients less than 6 months of age with an adrenal primary tumor \> 3.1 and \< 5 cm in greatest diameter OR
* \< 12 months of age with a non-adrenal primary site \< 5 cm in greatest diameter
* Group A2: =\< 6 months of age with an adrenal primary site and tumor =\< 3.1 cm in greatest diameter
* Group B: patients \< 18 months (\< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
* No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor \[abdominal compartment syndrome, urinary obstruction, etc.\]); horner syndrome is not considered neurologic compromise
* No prior tumor resection, tumor biopsy ONLY
* Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1
* Group C: patients \< 18 months (\< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma
* No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with MYCN amplified tumors are not eligible
* Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure
* Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study
Primary outcome measure(s)
Overall survival (OS) (Strata 1-4) — From date of enrollment until death or last contact, assessed up to 3 years The Kaplan-Meier method will be used to estimate the 3-year overall survival for each stratum. OS is measured from time of enrollment to the date of death from any cause.
Trial sites (222)
Facility
City
Region
Status
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
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Colorado
Connecticut Children's Medical Center
Hartford
Connecticut
Yale University
New Haven
Connecticut
Alfred I duPont Hospital for Children
Wilmington
Delaware
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
Children's National Medical Center
Washington D.C.
District of Columbia
Broward Health Medical Center
Fort Lauderdale
Florida
Golisano Children's Hospital of Southwest Florida
Fort Myers
Florida
UF Health Cancer Institute - Gainesville
Gainesville
Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Florida
Nemours Children's Clinic-Jacksonville
Jacksonville
Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
Nicklaus Children's Hospital
Miami
Florida
Miami Cancer Institute
Miami
Florida
AdventHealth Orlando
Orlando
Florida
+ 182 more sites — see the full list on the official registry below.
More Children's Oncology Group trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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