Trial · NCT03794349
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
NCT03794349, Phase 2, Active not recruiting, Children's Oncology Group; results first posted 2026-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma. Trials, record NCT03794349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03794349
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
- NCT number
- NCT03794349
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 94 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- High Risk Neuroblastoma, Recurrent Neuroblastoma, Refractory Neuroblastoma
- Interventions
- Dinutuximab, Eflornithine Hydrochloride, Irinotecan Hydrochloride, Sargramostim, Temozolomide
- First posted
- 2019-01-07
- Last updated
- 2026-02-18
- Results first posted
- 2026-01-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | After every 2 cycles, for a maximum of 6 cycles of treatment (each cycle is 21 days) | 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. |
| Secondary | Progression-free Survival (PFS) | Up to 1 year | Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up. 1-Year PFS is provided. |
| Secondary | Overall Survival (OS) | Up to 1 year | Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.1-Year OS is provided. |
| Secondary | Incidence of Adverse Events >= Grade 3 (Regimen B) | Up to 5 years | The percentage of patients on Regimen B with at least one Grade 3 or higher toxicity will be calculated, assessed with Common Terminology Criteria for Adverse Events version 5.0. |
| Other | Immune and Cytokine Profiles | Up to 6 cycles | Will be assessed by exploring the relationship between response (responder versus \[vs.\] non-responder) after 6 cycles on Regimen B with serum cytokine levels (IL1, IL6, tumor necrosis factor \[TNF\]-alpha, IFN-gamma, etc.), tumor resident immune cells (natural killer \[NK\] cells, tumor-associated macrophages \[TAMS\], tumor infiltrating lymphocyte \[TILS\]), and critical immune cell suppressing proteins (B7H3, PDL-1) using Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous factors. |
| Other | GD2 Levels in Tumor Cells From Bone Marrow Samples | Up to 5 years | Will be correlated with response (responder vs. non-responder) after 6 cycles using Fisher's exact test for categorical and the Wilcoxon rank-sum test for continuous factors. |
| Other | Patient Reported Pain and Opiate Usage | Up to 5 years | The occurrence of pain on each regimen as reported by patient report and opiate use will be descriptively summarized. Descriptive and summary statistics will be used to describe the scores from the Faces Pain Scale-Revised during the dinutuximab infusion and on day 1 with irinotecan and temozolomide alone for each arm separately. Confidence intervals will be constructed for the mean and frequency estimates. The day 1 patient reported outcome data are expected to be similar between the 2 regimens, while differences during or after completion of treatment may be observed. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | After every 2 cycles, for a maximum of 6 cycles of treatment (each cycle is 21 days) | All eligible patients | percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 1 year | All eligible patients | percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 1 year | All eligible patients | percentage of patients | NUMBER |
| SECONDARY | Incidence of Adverse Events >= Grade 3 (Regimen B) | Up to 5 years | All eligible patients | percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Immune and Cytokine Profiles | Up to 6 cycles | |||
| OTHER_PRE_SPECIFIED | GD2 Levels in Tumor Cells From Bone Marrow Samples | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Patient Reported Pain and Opiate Usage | Up to 5 years |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 63.6 | 95% Confidence Interval 48.9 to 76.2 | percentage of patients | |
| Response Rate | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 57.4 | 95% Confidence Interval 43.3 to 70.5 | percentage of patients | |
| Progression-free Survival (PFS) | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 66.9 | 95% Confidence Interval 52.1 to 81.7 | percentage of patients | |
| Progression-free Survival (PFS) | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 56.0 | 95% Confidence Interval 41.4 to 70.6 | percentage of patients | |
| Overall Survival (OS) | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 88.2 | 95% Confidence Interval 78.0 to 98.4 | percentage of patients | |
| Overall Survival (OS) | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 82.0 | 95% Confidence Interval 70.6 to 93.4 | percentage of patients | |
| Incidence of Adverse Events >= Grade 3 (Regimen B) | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 93.6 | percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 46 | |
| Overall Study | STARTED | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 48 | |
| Overall Study | COMPLETED | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 13 | |
| Overall Study | COMPLETED | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 16 | |
| Overall Study | NOT COMPLETED | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 33 | |
| Overall Study | NOT COMPLETED | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 32 |
Source ClinicalTrials.gov
Adverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 12 | 44 | |
| other | Anemia | Blood and lymphatic system disorders | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 21 | 47 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 4 | 44 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 1 | 47 | |
| other | Sinus tachycardia | Cardiac disorders | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 1 | 44 | |
| other | Sinus tachycardia | Cardiac disorders | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 0 | 47 | |
| other | Hearing impaired | Ear and labyrinth disorders | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 0 | 44 | |
| other | Hearing impaired | Ear and labyrinth disorders | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 5 | 47 | |
| other | Optic nerve disorder | Eye disorders | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 1 | 44 | |
| other | Optic nerve disorder | Eye disorders | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 0 | 47 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 13 | 44 |
| Total, all-cause mortality | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 19 | 47 |
| Total, other adverse events | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 34 | 44 |
| Total, other adverse events | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 39 | 47 |
| Total, serious adverse events | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | 3 | 44 |
| Total, serious adverse events | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 20 | 47 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38200233 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regimen A (Chemotherapy, Dinutuximab, Sargramostim) vs Regimen B (Eflornithine, Chemotherapy, Dinutuximab): deaths from any cause | Trial comparisons |
| Regimen A (Chemotherapy, Dinutuximab, Sargramostim) vs Regimen B (Eflornithine, Chemotherapy, Dinutuximab): serious adverse events | Trial comparisons |
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/NCT03794349
GET https://conductscience.org/api/trials/v1/NCT03794349/events?page=2