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NCT03794349 · ClinicalTrials.gov registry record · Phase 2
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
A Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT03794349: Active Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma, sponsored by Children's Oncology Group.
NCT03794349 is a Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 94 participants, above the 55-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03794349, a Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Responders are defined as patients who achieve a \>= minor response (MR) per the International Neuroblastoma Response Criteria (INRC) as their best overall response by the end of 6 cycles. The response rate to treatment will be calculated among all eligible patients, including placement of a 95% confidence interval on the response rate.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan Hydrochloride
- BIOLOGICAL Sargramostim
- BIOLOGICAL Dinutuximab
- DRUG Eflornithine Hydrochloride
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
What the registry record for NCT03794349 still lists
NCT03794349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 55-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (71% higher).
The record links to 3 conditions, with High-risk Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT03794349 names 20 study sites across 7 states, led by California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03794349 about?
NCT03794349 is a clinical study titled "Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma". 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 hydr...
What is the current status of trial NCT03794349?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-07-08. Estimated completion is 2029-03-31.
What conditions does trial NCT03794349 study?
This clinical trial studies the following conditions: High-risk Neuroblastoma, Refractory Neuroblastoma, Recurrent Neuroblastoma.
What interventions are being tested in trial NCT03794349?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan Hydrochloride (DRUG), Sargramostim (BIOLOGICAL), Dinutuximab (BIOLOGICAL), Eflornithine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03794349?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03794349 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High-risk Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03794349's enrollment target sits among peer trials
94 1st of 9 the highest of 9 other High-risk Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High-risk Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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