ClinicalTrials.gov record
Active, not recruiting Phase 2 Interventional Results available

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

ClinicalTrials.gov ID: NCT03794349

Public ClinicalTrials.gov record NCT03794349. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 4, 2026, 6:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

Study identification

NCT ID
NCT03794349
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Children's Oncology Group
Network
Enrollment
94 participants

Conditions and interventions

Interventions

  • Dinutuximab Biological
  • Eflornithine Hydrochloride Drug
  • Irinotecan Hydrochloride Drug
  • Sargramostim Biological
  • Temozolomide Drug

Biological · Drug

Eligibility (public fields only)

Age range
1 Year and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 7, 2019
Primary completion
Mar 30, 2025
Completion
Mar 30, 2029
Last update posted
Feb 17, 2026

2019 – 2029

United States locations

U.S. sites
124
U.S. states
43
U.S. cities
103
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233
Arkansas Children's Hospital Little Rock Arkansas 72202-3591
Kaiser Permanente Downey Medical Center Downey California 90242
Miller Children's and Women's Hospital Long Beach Long Beach California 90806
Children's Hospital Los Angeles Los Angeles California 90027
Cedars Sinai Medical Center Los Angeles California 90048
Valley Children's Hospital Madera California 93636
Kaiser Permanente-Oakland Oakland California 94611
Children's Hospital of Orange County Orange California 92868
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304
University of California Davis Comprehensive Cancer Center Sacramento California 95817
Rady Children's Hospital - San Diego San Diego California 92123
UCSF Medical Center-Mission Bay San Francisco California 94158
Children's Hospital Colorado Aurora Colorado 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218
Connecticut Children's Medical Center Hartford Connecticut 06106
Yale University New Haven Connecticut 06520
Alfred I duPont Hospital for Children Wilmington Delaware 19803
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007
Children's National Medical Center Washington D.C. District of Columbia 20010
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908
University of Florida Health Science Center - Gainesville Gainesville Florida 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida 33021
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136
Nicklaus Children's Hospital Miami Florida 33155
Arnold Palmer Hospital for Children Orlando Florida 32806
Nemours Children's Hospital Orlando Florida 32827
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701
Saint Mary's Medical Center West Palm Beach Florida 33407
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329
Memorial Health University Medical Center Savannah Georgia 31404
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826
Saint Luke's Cancer Institute - Boise Boise Idaho 83712
Lurie Children's Hospital-Chicago Chicago Illinois 60611
University of Illinois Chicago Illinois 60612
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637
Loyola University Medical Center Maywood Illinois 60153
Saint Jude Midwest Affiliate Peoria Illinois 61637
Riley Hospital for Children Indianapolis Indiana 46202
Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana 46260
Blank Children's Hospital Des Moines Iowa 50309
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536
Norton Children's Hospital Louisville Kentucky 40202
Children's Hospital New Orleans New Orleans Louisiana 70118
Ochsner Medical Center Jefferson New Orleans Louisiana 70121
Eastern Maine Medical Center Bangor Maine 04401
Maine Children's Cancer Program Scarborough Maine 04074
University of Maryland/Greenebaum Cancer Center Baltimore Maryland 21201
Sinai Hospital of Baltimore Baltimore Maryland 21215
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287
Dana-Farber Cancer Institute Boston Massachusetts 02215
C S Mott Children's Hospital Ann Arbor Michigan 48109
Children's Hospital of Michigan Detroit Michigan 48201
Wayne State University/Karmanos Cancer Institute Detroit Michigan 48201
Michigan State University East Lansing Michigan 48823
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503
Bronson Methodist Hospital Kalamazoo Michigan 49007
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455
University of Mississippi Medical Center Jackson Mississippi 39216
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108
Washington University School of Medicine St Louis Missouri 63110
Mercy Hospital Saint Louis St Louis Missouri 63141
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114
University of Nebraska Medical Center Omaha Nebraska 68198
University Medical Center of Southern Nevada Las Vegas Nevada 89102
Sunrise Hospital and Medical Center Las Vegas Nevada 89109
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada 89135
Summerlin Hospital Medical Center Las Vegas Nevada 89144
Renown Regional Medical Center Reno Nevada 89502
Hackensack University Medical Center Hackensack New Jersey 07601
Morristown Medical Center Morristown New Jersey 07960
Albany Medical Center Albany New York 12208
Roswell Park Cancer Institute Buffalo New York 14263
NYU Langone Hospital - Long Island Mineola New York 11501
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032
University of Rochester Rochester New York 14642
State University of New York Upstate Medical University Syracuse New York 13210
Montefiore Medical Center - Moses Campus The Bronx New York 10467
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203
Duke University Medical Center Durham North Carolina 27710
Wake Forest University Health Sciences Winston-Salem North Carolina 27157
Children's Hospital Medical Center of Akron Akron Ohio 44308
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106
Cleveland Clinic Foundation Cleveland Ohio 44195
Nationwide Children's Hospital Columbus Ohio 43205
Dayton Children's Hospital Dayton Ohio 45404
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio 43606
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Oregon Health and Science University Portland Oregon 97239
Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania 18103
Penn State Children's Hospital Hershey Pennsylvania 17033
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224
Rhode Island Hospital Providence Rhode Island 02903
Prisma Health Richland Hospital Columbia South Carolina 29203
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134
East Tennessee Childrens Hospital Knoxville Tennessee 37916
Saint Jude Children's Research Hospital Memphis Tennessee 38105
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232
Dell Children's Medical Center of Central Texas Austin Texas 78723
Driscoll Children's Hospital Corpus Christi Texas 78411
Medical City Dallas Hospital Dallas Texas 75230
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390
Cook Children's Medical Center Fort Worth Texas 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030
Children's Hospital of San Antonio San Antonio Texas 78207
Primary Children's Hospital Salt Lake City Utah 84113
University of Vermont and State Agricultural College Burlington Vermont 05405
University of Virginia Cancer Center Charlottesville Virginia 22908
Children's Hospital of The King's Daughters Norfolk Virginia 23507
Seattle Children's Hospital Seattle Washington 98105
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405
Madigan Army Medical Center Tacoma Washington 98431
West Virginia University Healthcare Morgantown West Virginia 26506
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03794349, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 17, 2026 · Synced May 4, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03794349 live on ClinicalTrials.gov.

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