Trial · NCT07027748
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
NCT07027748, Phase 1, Recruiting, Steven DuBois, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma. Trials, record NCT07027748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07027748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
- NCT number
- NCT07027748
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Steven DuBois, MD
- Conditions
- Neuroblastoma, Neuroblastoma Recurrent, Relapsed Neuroblastoma, Refractory Neuroblastoma
- Interventions
- Naxitamab, Irinotecan, Temozolomide, Sargramostim granulocyte-macrophage colony stimulating factor
- First posted
- 2025-06-18
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended duration of naxitamab infusion | Assessed at the end of the first cycle of treatment, where 1 cycle is 21 days | 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. |
| Secondary | Frequency of severe infusion related pain as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) | Assessed days 1 and 8 for Cycles 1 through 6, where 1 cycle is 21 days | Frequency of CTCAE severe infusion related pain is defined as the count of all participants that experience a grade 3 or higher pain event as measured by CTCAE version 5. |
| Secondary | Frequency of severe infusion related pain as measured by the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PEDS PRO-CTCAE) | Assessed days 1 and 8 for Cycles 1 through 6, where 1 cycle is 21 days | Frequency of PEDS PRO-CTCAE severe infusion related pain is defined as the count of all participants that experience a score of 3 or greater on Question 1b of the PRO-CTCAE instrument. |
| Secondary | Frequency of grade 3 or higher infusion related pain as measured by The Face, Legs, Activity, Cry, and Consolability (FLACC) Scale | Assessed on every naxitamab infusion day (days 1, 3, and 5) for both Cycle 1 and 2, where 1 cycle is 21 days | Frequency of FLACC severe infusion related pain is defined as the count of all participants that experience a score of 7 or greater on the FLACC scale instrument. |
| Secondary | Frequency of grade 3 or higher infusion related pain as measured by the Wong-Baker FACES scale | Assessed on every naxitamab infusion day (days 1, 3, and 5) for both Cycle 1 and 2, where 1 cycle is 21 days | Frequency of FACES severe infusion related pain is defined as the count of all participants that experience a score of 4 or greater on the Wong-Baker FACES instrument. |
| Secondary | Frequency of grade 3 or higher related pain as measured by the Numeric Rating Scale (NRS) | Assessed on every naxitamab infusion day (days 1, 3, and 5) for both Cycle 1 and 2, where 1 cycle is 21 days | Frequency of NRS severe infusion related pain is defined as the count of all participants that experience a score of 7 or greater on the Numeric Rating Scale (NRS) instrument. |
| Secondary | Frequency of additional infusion-related toxicity | Assessed at each clinic visit throughout the duration of treatment and for 35 days following the last dose of treatment, approximately 161 days | Frequency of additional infusion-related toxicity will be defined as the count of toxicities which necessitate additional supportive care or interventions (i.e. an outpatient that requires hospital admission; an inpatient that requires ICU transfer). |
| Secondary | Overall Best Response | Assessed at the end of 6 cycles of protocol chemoimmunotherapy, approximately 126 days | Overall best response (as defined per International Neuroblastoma Response Committee criteria) at or before the end of 6 cycles of protocol chemoimmunotherapy. |
| Secondary | Progression-Free Survival (PFS) | Assessed quarterly until withdrawal of consent or completion of the study (1 year follow-up after last treatment dose given to last enrolled patient). | PFS time, defined as time from first response until first occurrence of relapse, progression, or death due to disease. Participants without an event will be censored at the time of last contact. |
| Secondary | Overall Survival (OS) | Assessed quarterly until withdrawal of consent or completion of the study (1 year follow-up after last treatment dose given to last enrolled patient). | OS time, defined as the time from first study treatment to death due to any cause, or censored at date of last contact. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07027748
GET https://conductscience.org/api/trials/v1/NCT07027748/registered