Trial · NCT01041638
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT01041638, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2015-02-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma. Trials, record NCT01041638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041638
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma
- NCT number
- NCT01041638
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 105 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- High Risk Neuroblastoma
- Interventions
- Aldesleukin, Diagnostic Laboratory Biomarker Analysis, Dinutuximab, Isotretinoin, Sargramostim
- First posted
- 2010-01-01
- Last updated
- 2026-06-24
- Results first posted
- 2015-02-19
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 Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Up to 6 courses of therapy | Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported. |
| Secondary | Event-free Survival (EFS) | From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years | Event-free Survival (EFS) for all eligible patients enrolled on the study |
| Secondary | Overall Survival (OS) | From enrollment until death, or until last contact with the patient, up to 3 years | Overall Survival (OS) for all eligible patients enrolled on the study |
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 Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Up to 6 courses of therapy | There was one patient that did not receive treatment, represented on the baseline form as withdrawal by patient, not included in outcome measure tabulation. | percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) | From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years | All eligible patients. | percentage | NUMBER |
| SECONDARY | Overall Survival (OS) | From enrollment until death, or until last contact with the patient, up to 3 years | All eligible patients | percentage | NUMBER |
Source ClinicalTrials.gov
Results by group92
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 Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Abdominal pain (10300), course 1 | 17.3077 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Abdominal pain (10300), course 2 | 5.0000 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Abdominal pain (10300), course 3 | 6.1224 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Abdominal pain (10300), course 4 | 4.4444 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Abdominal pain (10300), course 5 | 5.6818 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Abdominal pain (10300), course 6 | 0.00000 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Allergic reaction (12000), Course 1 | 1.92308 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Allergic reaction (12000), Course 2 | 5.00000 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Allergic reaction (12000), Course 3 | 3.06122 | percentage of participants | |
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Allergic reaction (12000), Course 4 | 2.22222 | percentage of participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 105 | |
| Overall Study | COMPLETED | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 78 | |
| Overall Study | NOT COMPLETED | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 27 |
Source ClinicalTrials.gov
Adverse events357
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 | 13200-Anemia | Blood and lymphatic system disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 99 | 104 | 1,181 |
| other | 17200-Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 2 | 104 | 2 |
| other | 18100-Bone marrow hypocellular | Blood and lymphatic system disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 1 | 104 | 1 |
| other | 25800-Disseminated intravascular coagulation | Blood and lymphatic system disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 1 | 104 | 1 |
| other | 20100-Cardiac disorders - Other | Cardiac disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 6 | 104 | 16 |
| other | 21300-Chest pain - cardiac | Cardiac disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 3 | 104 | 3 |
| other | 61000-Palpitations | Cardiac disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 2 | 104 | 2 |
| other | 63100-Pericardial effusion | Cardiac disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 2 | 104 | 3 |
| other | 74200-Sinus bradycardia | Cardiac disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 7 | 104 | 18 |
| other | 74500-Sinus tachycardia | Cardiac disorders | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 85 | 104 | 740 |
1 to 10 of 357Source ClinicalTrials.gov
See all 357 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | ||
| Total, other adverse events | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 104 | 104 |
| Total, serious adverse events | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | 103 | 104 |
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 |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
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/NCT01041638
GET https://conductscience.org/api/trials/v1/NCT01041638/results?page=2