Trial · NCT03786783
Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
NCT03786783, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma. Trials, record NCT03786783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03786783
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
- NCT number
- NCT03786783
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Ganglioneuroblastoma, High Risk Neuroblastoma
- Interventions
Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, Cisplatin, Cyclophosphamide, Dexrazoxane, Dinutuximab, Doxorubicin, Etoposide, External Beam Radiation Therapy, Isotretinoin, Melphalan, Sargramostim, Thiotepa, Topotecan, Vincristine
- First posted
- 2018-12-26
- Last updated
- 2026-06-02
- Results first posted
- 2023-03-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Unacceptable Toxicity | Up to the first 5 cycles of treatment | Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Assessed by estimation of the combined toxic death and unacceptable toxicity rate during Induction cycles 3-5 together with a 95% confidence interval. |
| Primary | Percentage of Participants Who Are Feasibility "Failure" | Up to the first 5 cycles of treatment | Feasibility "failures" were defined as patients that did not receive \>= 75% of the planned dinutuximab doses during Induction cycles 3-5. Assessed by estimation of the feasibility "failure" rate together with a 95% confidence interval. |
| Secondary | Response Rate | Up to the first 5 cycles of treatment | Per the revised INRC, response is comprised by responses in 3 components: primary tumor, soft tissue and bone metastases, and bone marrow. Primary and metastatic soft tissue sites were assessed using Response Evaluation Criteria in Solid Tumors and MIBG scans or FDG-PET scans if the tumor was MIBG non-avid. Bone marrow was assessed by histology or immunohistochemistry and cytology or immunocytology. Complete response (CR) - All components meet criteria for CR. Partial response (PR) - PR in at least one component and all other components are either CR, minimal disease (in bone marrow), PR (soft tissue or bone) or not involved (NI; no component with progressive disease (PD). Minor response (MR) - PR or CR in at least one component but at least one other component with stable disease; no component with PD. Stable disease (SD) - Stable disease in one component with no better than SD or NI in any other component; no component with PD. Progressive disease (PD) - Any component with PD. |
| Secondary | Event-free Survival | Up to 1 year | Per the revised INRC, progressive disease is: 1) \> 20% increase in the longest diameter of the primary tumor, taking as reference the smallest sum and ¬\> increase of 5 mm in longest dimension, 2) Any new soft tissue lesion detected by CT/MRI that is MIBG avid or FDG-PET avid, 3) Any new soft tissue lesion seen on CT/MRI that is biopsied and found to be neuroblastoma or ganglioneuroblastoma, 4) Any new bone site that is MIBG avid, 5) Any new bone site that is FDG-PET avid and has CT/MRI findings of tumor or is histologically neuroblastoma or ganglioneuroblastoma 6) A metastatic soft tissue site with \> 20% increase in longest diameter, taking as reference the smallest sum on study, and with \> 5mm in sum of diameters of target soft tissue lesions, 7) A relative MIBG score ¬\> 1.2, 8) Bone marrow without tumor infiltration that becomes \>5% tumor infiltration, 9) Bone marrow with tumor infiltration that increases by \> 2-fold and has \> 20% tumor infiltration on reassessment. |
| Secondary | Overall Survival | Up to 1 year | Kaplan-Meier method was used to estimate overall survival (OS). OS was defined as the time from study enrollment to death. 1-year OS is provided. |
| Other | Incidence of Naturally Occurring Anti-glycan Antibodies | Up to 5 years | The Incidence of Naturally Occurring Anti-glycan Antibodies was calculated, including placement of a 95% CI on the incidence. In addition, anti-glycan levels prior to the start of Induction therapy and prior to the start of post-Consolidation therapy was compared with Wilcoxon's signed-rank test for paired data. |
| Other | Incidence of Natural Killer (NK) Receptor NKp30 Isoforms | Up to 5 years | Assessed by calculating the incidence of NK receptor NKp30 isoforms, including placement of a 95% CI on the incidence. |
| Other | Response of Host Factors, Including Naturally Occurring Anti-glycan Antibodies, KIR/KIR-L Genotyping, Fc Receptor Genotyping, Human Anti-chimeric Antibodies (HACA) | Up to 5 years | Explored with Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous host factors. Both the presence/absence and level of naturally occurring anti-glycan antibodies was considered. For the KIR/KIR-L analysis, patients were categorized as either matched or mismatched. Patients were grouped into one of the three genotype subgroups of Fc receptor genotyping for that analysis. The presence/absence of HACA, anti-idiotype, and pretreatment anti-therapeutic antibodies (PATA)/anti-allotype antibody was considered for the HACA analysis. |
| Other | Immune Environment (Gene Expression; Immune Effector Cells, Activities and Signaling Molecules; Immune Target Expression) | Up to 5 years | The incidence of NK receptor NKp30 isoforms was calculated, including placement of a 95% CI on each incidence rate. Summary statistics were generated for serum cytokine (IL6, CXCL9) levels and gene expression of circulating immune function cells. |
| Other | Levels of Circulating GD2 and Tumor Cell GD2 Expression | Up to 5 years | Assessed by exploring the relationship between response to treatment with \> PR (response vs. non- response) with circulating GD2 levels, and GD2 tumor cell expression following therapy with a Wilcoxon rank-sum test. Changes from baseline were also analyzed. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Unacceptable Toxicity | Up to the first 5 cycles of treatment | All eligible patients who received at least one dose of ch14.18 (dinutuximab) during Induction cycles | percentage of patients | NUMBER |
| PRIMARY | Percentage of Participants Who Are Feasibility Failure | Up to the first 5 cycles of treatment | All eligible patients who received at least one dose of ch14.18 (dinutuximab) during Induction cycles | Percentage of patients | NUMBER |
| SECONDARY | Response Rate | Up to the first 5 cycles of treatment | All eligible patients. Institutional assessment of end-induction response has been used. | Percentage of patients | NUMBER |
| SECONDARY | Event-free Survival | Up to 1 year | All eligible patients. | Percent Probability | NUMBER |
| SECONDARY | Overall Survival | Up to 1 year | All eligible patients. | Percent Probability | NUMBER |
| OTHER_PRE_SPECIFIED | Incidence of Naturally Occurring Anti-glycan Antibodies | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Incidence of Natural Killer (NK) Receptor NKp30 Isoforms | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Response of Host Factors, Including Naturally Occurring Anti-glycan Antibodies, KIR/KIR-L Genotyping, Fc Receptor Genotyping, Human Anti-chimeric Antibodies (HACA) | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Immune Environment (Gene Expression; Immune Effector Cells, Activities and Signaling Molecules; Immune Target Expression) | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Levels of Circulating GD2 and Tumor Cell GD2 Expression | Up to 5 years |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Unacceptable Toxicity | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of patients | |
| Percentage of Participants Who Are Feasibility Failure | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 0.0 | 95% Confidence Interval 0.0 to 0.0 | Percentage of patients | |
| Response Rate | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 78.6 | 95% Confidence Interval 64.1 to 88.3 | Percentage of patients | |
| Event-free Survival | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 82.6 | 95% Confidence Interval 70.8 to 94.4 | Percent Probability | |
| Overall Survival | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 95.0 | 95% Confidence Interval 88.1 to 100.0 | Percent Probability |
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(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 42 | |
| Overall Study | COMPLETED | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 22 | |
| Overall Study | NOT COMPLETED | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 20 |
Source ClinicalTrials.gov
Adverse events115
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 | Abdominal pain | Gastrointestinal disorders | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 2 | 42 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 1 | 42 | |
| other | Acute kidney injury | Renal and urinary disorders | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 3 | 42 | |
| other | Alanine aminotransferase increased | Investigations | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 11 | 42 | |
| other | Alkaline phosphatase increased | Investigations | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 1 | 42 | |
| other | Allergic reaction | Immune system disorders | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 1 | 42 | |
| other | Anal mucositis | Gastrointestinal disorders | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 3 | 42 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 6 | 42 | |
| other | Anorectal infection | Infections and infestations | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 1 | 42 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 21 | 42 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 1 | 42 |
| Total, other adverse events | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 42 | 42 |
| Total, serious adverse events | Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 14 | 42 |
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/NCT03786783
GET https://conductscience.org/api/trials/v1/NCT03786783/events?page=2