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Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
NCT03794349 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03794349
The ClinicalTrials.gov registry entry for NCT03794349 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Refractory Neuroblastoma appearing as the primary indexed condition, and to 5 interventions — of which Temozolomide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03794349 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Refractory Neuroblastoma, Recurrent Neuroblastoma, High Risk Neuroblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03794349?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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