Trial · NCT04385277
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
NCT04385277, Phase 2, Active not recruiting, Children's Oncology Group; results first posted 2024-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL). Trials, record NCT04385277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04385277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
- NCT number
- NCT04385277
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Ganglioneuroblastoma, Nodular, Neuroblastoma
- Interventions
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Dinutuximab, FDG-Positron Emission Tomography, Iobenguane I-123, Irinotecan, Isotretinoin, Magnetic Resonance Imaging, Multigated Acquisition Scan, Sargramostim, Temozolomide
- First posted
- 2020-05-12
- Last updated
- 2025-10-27
- Results first posted
- 2024-08-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Complete 5 Cycles of Dinutuximab + Chemotherapy Without Progressive Disease (PD) | Within 30 weeks from the date of first treatment | Will be assessed by estimation of the feasibility therapy completion rate together with a 95% Wilson confidence interval (CI). |
| Secondary | Event-free Survival (EFS) | From the time of start of protocol therapy to the occurrence of disease relapse or progression, secondary malignancy, or death, assessed at 1 year. | EFS Kaplan-Meier estimates will be generated. |
| Secondary | Overall Survival (OS) | From the time of start of protocol therapy to death, assessed at 1 year. | OS Kaplan-Meier estimates will be generated. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Complete 5 Cycles of Dinutuximab + Chemotherapy Without Progressive Disease (PD) | Within 30 weeks from the date of first treatment | All eligible patients who receive at least one dose of dinutuximab in combination with irinotecan and temozolomide, GM-CSF, and isotretinoin | Percentage of patients | NUMBER |
| SECONDARY | Event-free Survival (EFS) | From the time of start of protocol therapy to the occurrence of disease relapse or progression, secondary malignancy, or death, assessed at 1 year. | All eligible patients | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From the time of start of protocol therapy to death, assessed at 1 year. | All eligible patients | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Complete 5 Cycles of Dinutuximab + Chemotherapy Without Progressive Disease (PD) | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 87.50 | 95% Confidence Interval 73.89 to 94.54 | Percentage of patients | |
| Event-free Survival (EFS) | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 90.0 | 95% Confidence Interval 80.71 to 99.29 | percentage of participants | |
| Overall Survival (OS) | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 97.5 | 95% Confidence Interval 92.66 to 100 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 41 | |
| Overall Study | COMPLETED | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 36 | |
| Overall Study | NOT COMPLETED | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 5 |
Source ClinicalTrials.gov
Adverse events54
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 | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 2 | 40 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 7 | 40 | |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 1 | 40 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 1 | 40 | |
| other | Dental caries | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 1 | 40 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 4 | 40 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 1 | 40 | |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 1 | 40 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 1 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 2 | 40 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 2 | 40 |
| Total, other adverse events | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 34 | 40 |
| Total, serious adverse events | Treatment (Temozolomide, Irinotecan, Dinutuximab) | 3 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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/NCT04385277
GET https://conductscience.org/api/trials/v1/NCT04385277/events?page=2