ClinicalTrials.gov record
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Study identification
- NCT ID
- NCT03794349
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- 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 8, 2019 (Actual)
- Primary completion
- Mar 31, 2025 (Actual)
- Completion
- Mar 31, 2029 (Estimated)
- Last update posted
- Feb 18, 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 18, 2026 · Synced Oct 26, 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 public registry record, listed eligibility criteria, and available contact information for NCT03794349 live on ClinicalTrials.gov.