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NCT07027748 · ClinicalTrials.gov registry record · Phase 1
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
A Phase 1 study of Neuroblastoma and Refractory Neuroblastoma, sponsored by Steven DuBois, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT07027748: Recruiting Phase 1 study of Neuroblastoma and Refractory Neuroblastoma, sponsored by Steven DuBois, MD.
NCT07027748 is a Phase 1 study of Neuroblastoma and Refractory Neuroblastoma that is actively recruiting participants, run by Steven DuBois, MD. The registered enrollment target is 18 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07027748, a Phase 1 study of Neuroblastoma and Refractory Neuroblastoma, is actively recruiting participants, sponsored by Steven DuBois, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
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)
Primary Outcome
The duration of naxitamab infusion that is safe and tolerable will be measured using the endpoint of an occurrence of any dose limiting toxicity. A modified 3+3 design will be used, where the 'modification' permits a single duration level de-escalation in addition to the typical duration group level escalation.
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 |
What NCT07027748 shows while recruiting
NCT07027748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower).
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.
NCT07027748 reports a single indexed study location in Massachusetts.
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.
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).
Who is sponsoring clinical trial NCT07027748?
This trial is sponsored by Steven DuBois, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07027748's enrollment target sits among peer trials
18 77th of 94 higher than 14 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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