Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT ID: NCT00026312
Last Updated: 2025-11-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1449 participants
INTERVENTIONAL
2001-10-18
2026-03-19
Brief Summary
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Detailed Description
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I. Determine if monoclonal antibody Ch14.18 (dinutuximab) + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-autologous stem cell transplant (ASCT) response of complete response (CR), very good partial response (VGPR), or partial response (PR).
SECONDARY OBJECTIVES:
I. Determine if monoclonal antibody Ch14.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves overall survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR.
II. Determine if immunotherapy + RA improves event free survival and overall survival as compared to RA alone, in the subgroup of high risk International Neuroblastoma Staging System (INSS) stage 4 neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR.
III. Determine the toxicities of the combination of monoclonal antibody Ch14.18 with cytokines.
IV. To compare the outcome data of the patients with persistent disease documented by biopsy (Stratum 07) to the historical data for the analogous patients from Children's Cancer Group (CCG)-3981.
V. To further describe and refine the event free survival (EFS) and overall survival (OS) estimates and baseline characteristics for subjects receiving Ch14.18 + cytokines + RA, following cessation of the randomized portion of the study.
VI. To further describe the safety and toxicity of Ch14.18 + cytokines + RA under the new administration guidelines implemented following cessation of the randomized portion of the study with focus on: a) number of courses delivered per subject; b) number of dose reductions or stoppage (ch14.18 and/or interleukin \[IL\]-2); and c) number of toxic deaths.
TERTIARY OBJECTIVES:
I. In the subgroup of neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR, determine if there is a difference between the two randomized regimens in reducing the minimal residual disease (MRD) burden as detected by the following parameters: meta-iodobenylguanidine (MIBG) scan, immunocytology (IC) of blood and bone marrow samples, reverse transcriptase-polymerase chain reaction (RT-PCR) for tyrosine hydroxylase, phosphoglycolate phosphatase (PGP) 9.5, and melanoma antigen family A, 1 (MAGE-1) in blood and bone marrow.
II. Determine if change from baseline of MRD is associated with event free and overall survival.
III. Determine whether tumor biology at diagnosis correlates with event-free and overall survival, for either of the randomized regimens.
IV. To explore the relationship between antibody-dependent cellular cytoxicity (ADCC) and EFS.
V. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.
VI. To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity.
VII. To determine the potential effect of ch14.18 on cardiac repolarization and to evaluate ch14.18 plasma levels.
VIII. To determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions and blood levels of ch14.18.
IX. To determine if the genotype of Fc receptor (FcR) and killer cell immunoglobulin-like receptor (Kir)/Kir-ligand correlate with EFS.
X. To determine if natural killer cell p30-related protein (NKp30) isoform expression and single nucleotide polymorphism (SNP), and circulating ligand B7-H6 are prognostic of EFS or OS.
OUTLINE: Patients stratified with biopsy-confirmed post-ASCT persistent disease who are also enrolled on Children's Oncology Group (COG)-A3973 or COG-ANBL0532 are assigned to treatment Arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms.
ARM I: Beginning on day 56-85 post-ASCT, patients receive isotretinoin orally (PO) twice daily (BID) for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy. (closed to accrual as of 4/16/2009)
ARM II: Beginning on day 56-85 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or intravenously (IV) over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.
After completion of study treatment, patients are followed up periodically for 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive isotretinoin PO BID for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy.
Isotretinoin
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive immunotherapy comprising sargramostim SC or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.
Aldesleukin
Given IV
Dinutuximab
Given IV
Isotretinoin
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Sargramostim
Given IV or SC
Interventions
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Aldesleukin
Given IV
Dinutuximab
Given IV
Isotretinoin
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Sargramostim
Given IV or SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include:
* Following treatment per A3973 protocol
* Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol
* Following treatment per CCG3891
* Following treatment on New Approaches to Neuroblastoma Therapy (NANT) 2001-02
* Enrollment on or following treatment per ANBL02P1
* Enrollment on or following treatment per ANBL07P1
* Tandem transplant patients are eligible:
* Following treatment on or per ANBL0532
* Following treatment per POG 9640
* Following treatment per COG ANBL00P1
* Following treatment per CHP 594/Dana-Farber Cancer Institute (DFCI) 34-DAT
* No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT except for the rare occasions as noted below; for tandem ASCT patients, this will be the date of the FIRST stem cell infusion; exception: for those who are initially diagnosed as non-high risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma, the 12 months restriction should start from the date of induction therapy for high risk neuroblastoma (not from the initial induction therapy for non-high risk disease), to the date of ASCT
* At pre-ASCT evaluation patients must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below:
* =\< 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
* Patient who have no tumor seen on the prior bone marrow, and then have =\< 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible (note that per INRC this would have been defined as "overall" response of progressive disease \[PD\])
* Prior to enrollment on ANBL0032, a determination of mandatory disease staging must be performed (tumor imaging studies including computed tomography \[CT\] or magnetic resonance imaging \[MRI\], MIBG scan, and vanillylmandelic acid \[VMA\]/homovanillic acid \[HVA\]; bone marrow aspirates are required but biopsy may be omitted if negative prior to ASCT); this disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before enrollment
* For those with residual disease before radiotherapy, re-evaluation of irradiated residual tumors is preferably performed at the earliest 5 days after completing radiotherapy; patients with residual disease are eligible; biopsy is not required; patients who have biopsy proven residual disease after ASCT will be enrolled on Stratum 07
* Patients must not have progressive disease at the time of study enrollment except for protocol specified bone marrow response and except for elevations of catecholamines as the only sign of disease in a patient who had normal catecholamines at pre-ASCT evaluation
* Patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than ten (10) calendar days after the date of study enrollment; patients should be enrolled preferably between day 56 and day 85 after peripheral blood stem cell (PBSC) infusion (day from 2nd stem cell infusion for tandem transplant); patients must be enrolled no later than day 200 after PBSC infusion; enrollment must occur after completion of radiotherapy, and after completion of tumor assessment post-ASCT and radiotherapy; informed consent should be obtained within 3 weeks pre-ASCT up to the time of registration
* Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy
* Patients must have a Lansky or Karnofsky performance scale score of \>= 50% and patients must have a life expectancy of \>= 2 months
* Total absolute phagocyte count (APC = %neutrophils + %monocytes) X white blood cell (WBC) is at least 1000/uL
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* No greater than 0.4 mg/dL (1 month to \< 6 months)
* No greater than 0.5 mg/dL (6 months to \< 1 year)
* No greater than 0.6 mg/dL (1 to \< 2 years)
* No greater than 0.8 mg/dL (2 to \< 6 years)
* No greater than 1.0 mg/dL (6 to \< 10 years)
* No greater than 1.2 mg/dL (10 to \< 13 years)
* No greater than 1.4 mg/dL (\>= 13 years \[female\])
* No greater than 1.5 mg/dL (13 to \< 16 years \[male\])
* No greater than 1.7 mg/dL (\>= 16 years \[male\])
* Total bilirubin =\< 1.5 x normal
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 5 x normal
* Veno-occlusive disease, if present, should be stable or improving
* Shortening fraction of \>= 27% by echocardiogram, or if shortening fraction abnormal, ejection fraction of \>= 55% by gated radionuclide study or echocardiogram; note: the echocardiogram or gated radionuclide study must be performed within 4 weeks prior to enrollment
* Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) \> 60% predicted by pulmonary function test; for children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest and no exercise intolerance should be documented; note: the pulmonary function test must be performed within 4 weeks prior to enrollment
* Patients with seizure disorder may be enrolled if on anticonvulsants and well-controlled; central nervous system (CNS) toxicity \< grade 2
* Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian
* Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Alice L Yu
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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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
Lee Memorial Health System
Fort Myers, Florida, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, 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
University of Arkansas for Medical Sciences
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
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
UCSF Medical Center-Parnassus
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, 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
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 Clinic - Orlando
Orlando, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, 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
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, 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
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 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
Maine Children's Cancer Program
Scarborough, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 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
C S Mott Children's Hospital
Ann Arbor, 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 - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, 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
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Hospital
Asheville, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States
Mercy Children's Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Carilion Children's
Roanoke, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, Australia
Sydney Children's Hospital
Randwick, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Children's Hospital-Brisbane
Herston, Queensland, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Children's Hospital
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, , Canada
Starship Children's Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
San Jorge Children's Hospital
San Juan, , Puerto Rico
Countries
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References
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Oesterheld J, Ferguson W, Kraveka JM, Bergendahl G, Clinch T, Lorenzi E, Berry D, Wada RK, Isakoff MS, Eslin DE, Brown VI, Roberts W, Zage P, Harrod VL, Mitchell DS, Hanson D, Saulnier Sholler GL. Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons. J Clin Oncol. 2024 Jan 1;42(1):90-102. doi: 10.1200/JCO.22.02875. Epub 2023 Oct 26.
Desai AV, Gilman AL, Ozkaynak MF, Naranjo A, London WB, Tenney SC, Diccianni M, Hank JA, Parisi MT, Shulkin BL, Smith M, Moscow JA, Shimada H, Matthay KK, Cohn SL, Maris JM, Bagatell R, Sondel PM, Park JR, Yu AL. Outcomes Following GD2-Directed Postconsolidation Therapy for Neuroblastoma After Cessation of Random Assignment on ANBL0032: A Report From the Children's Oncology Group. J Clin Oncol. 2022 Dec 10;40(35):4107-4118. doi: 10.1200/JCO.21.02478. Epub 2022 Jul 15.
Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, Shimada H, Grupp SA, Seeger R, Reynolds CP, Buxton A, Reisfeld RA, Gillies SD, Cohn SL, Maris JM, Sondel PM; Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324-34. doi: 10.1056/NEJMoa0911123.
Other Identifiers
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NCI-2009-01064
Identifier Type: REGISTRY
Identifier Source: secondary_id
s14-01661
Identifier Type: -
Identifier Source: secondary_id
COG-ANBL0032
Identifier Type: -
Identifier Source: secondary_id
PANBL0032_A33PAMDREVW01
Identifier Type: -
Identifier Source: secondary_id
CDR0000069018
Identifier Type: -
Identifier Source: secondary_id
ANBL0032
Identifier Type: -
Identifier Source: secondary_id
ANBL0032
Identifier Type: OTHER
Identifier Source: secondary_id
ANBL0032
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-01064
Identifier Type: -
Identifier Source: org_study_id
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