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Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
NCT07027748 · View on ClinicalTrials.gov ↗
Study Summary
This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma. The name of the study drugs involved in this study are: * Naxitamab (A type of monoclonal antibody) * Irinotecan (A standard of care chemotherapy) * Temozolomide (A standard of care chemotherapy) * Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)
Conditions Studied
Interventions
- DRUG Naxitamab
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Sargramostim granulocyte-macrophage colony stimulating factor
Study Locations (2)
Massachusetts
- Boston Children's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-06-27 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07027748
The ClinicalTrials.gov registry entry for NCT07027748 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steven DuBois, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 4 interventions — of which Naxitamab 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: NCT07027748 reports 2 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. 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 NCT07027748 about?
NCT07027748 is a clinical study titled "Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma". This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma. The name of the study dru...
What is the current status of trial NCT07027748?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-06-27. Estimated completion is 2027-12-01.
What conditions does trial NCT07027748 study?
This clinical trial studies the following conditions: Neuroblastoma, Refractory Neuroblastoma, Relapsed Neuroblastoma, Neuroblastoma Recurrent. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07027748?
The interventions under investigation include: Naxitamab (DRUG), Temozolomide (DRUG), Irinotecan (DRUG), Sargramostim granulocyte-macrophage colony stimulating factor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07027748?
This trial is sponsored by Steven DuBois, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07027748 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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