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ACTIVE NOT RECRUITING

NCT02176967

PHASE3

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

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

Summary

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.

Official title: Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma

Key Details

Gender

All

Age Range

Any - 18 Months

Study Type

INTERVENTIONAL

Enrollment

391

Start Date

2014-08-08

Completion Date

2027-10-06

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Neuroblastoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Carboplatin

Given IV

OTHER

Clinical Observation

Undergo clinical observation

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Ultrasound

Undergo ultrasound

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

Locations (222)

Children's Hospital of Alabama

Birmingham, Alabama, United States

USA Health Strada Patient Care Center

Mobile, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Banner Children's at Desert

Mesa, Arizona, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center

Downey, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Valley Children's Hospital

Madera, California, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Children's Hospital of Orange County

Orange, California, United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

Naval Medical Center -San Diego

San Diego, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Saint Mary's Medical Center

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, United States

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, United States

OSF Children's Hospital of Illinois

Peoria, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

IU Health North Hospital

Carmel, Indiana, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, United States

Blank Children's Hospital

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Maine Children's Cancer Program

Scarborough, Maine, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Tufts Children's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Michigan State University

East Lansing, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Corewell Health Children's

Royal Oak, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Missouri Children's Hospital

Columbia, Missouri, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

And 122 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (222)