Trial · NCT00026312

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

NCT00026312, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2017-03-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma. Trials, record NCT00026312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00026312

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT number: NCT00026312
Status: Completed
Phases: Phase 3
Enrollment: 1,449 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
Interventions: Aldesleukin, Dinutuximab, Isotretinoin, Laboratory Biomarker Analysis, Pharmacological Study, Quality-of-Life Assessment, Sargramostim
First posted: 2003-01-27
Last updated: 2026-03-05
Results first posted: 2017-03-29

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event-Free Survival (EFS)	Three years	Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only
Secondary	Event-Free Survival (EFS)	Three years	Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.
Secondary	Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial	Three years	EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.
Secondary	Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0	From enrollment to follow-up	Proportion of patients experiencing at least one Grade 3 or higher toxicity.
Secondary	Number of Courses of Therapy Delivered	Courses 1-6	Number of courses of therapy delivered for patients randomized to RA + Immunotherapy vs. patients non-randomly assigned to RA + Immunotherapy, excluding patients with persistent disease.
Secondary	Overall Survival (OS)	Three years	Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.
Secondary	Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial	Three years	OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.
Other	Average Level of HACA	Up to 10 years	The average level of HACA at each collection time point during immunotherapy will be calculated.
Other	Cardiac Repolarization	Up to 10 years	In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate.
Other	Change in MRD	Baseline to up to 10 years	A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-Free Survival (EFS)	Three years	Eligible, randomized patients.	Percentage of participants	NUMBER
SECONDARY	Event-Free Survival (EFS)	Three years	Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.	Percentage of participants	NUMBER
SECONDARY	Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial	Three years	Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.	Percentage of participants	NUMBER
SECONDARY	Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0	From enrollment to follow-up	Eligible patients enrolled prior to halting of randomization.	Proportion	NUMBER
SECONDARY	Number of Courses of Therapy Delivered	Courses 1-6	Eligible patients assigned to Regimen B, excluding patients with persistent disease.	courses per patient	MEDIAN
SECONDARY	Overall Survival (OS)	Three years	Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.	Percentage of participants	NUMBER
SECONDARY	Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial	Three years	Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease	Percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Average Level of HACA	Up to 10 years
OTHER_PRE_SPECIFIED	Cardiac Repolarization	Up to 10 years
OTHER_PRE_SPECIFIED	Change in MRD	Baseline to up to 10 years

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Event-Free Survival (EFS)	Regimen A		48.1	95% Confidence Interval 38.4 to 57.8	Percentage of participants
Event-Free Survival (EFS)	Regimen B		62.9	95% Confidence Interval 54.0 to 71.9	Percentage of participants
Event-Free Survival (EFS)	Regimen A	Randomized patients with INSS Stage 4 disease	43.2	95% Confidence Interval 32.5 to 53.8	Percentage of participants
Event-Free Survival (EFS)	Regimen B	Randomized patients with INSS Stage 4 disease	59.7	95% Confidence Interval 49.5 to 69.9	Percentage of participants
Event-Free Survival (EFS)	Regimen B	Eligible patients with persistent disease	35.1	95% Confidence Interval 19.8 to 50.5	Percentage of participants
Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial	Regimen B		64.0	95% Confidence Interval 60.2 to 67.8	Percentage of participants
Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0	Regimen A		0.64	95% Confidence Interval 0.55 to 0.73	Proportion
Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0	Regimen B		0.94	95% Confidence Interval 0.90 to 0.98	Proportion
Number of Courses of Therapy Delivered	Regimen B	Randomized to Regimen B - RA + Immunotherapy	6	Full Range 0 to 6	courses per patient
Number of Courses of Therapy Delivered	Regimen B	Non-randomly assigned after halting randomization	6	Full Range 0 to 6	courses per patient

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen A	116
Overall Study	STARTED	Regimen B	1,333
Overall Study	COMPLETED	Regimen A	82
Overall Study	COMPLETED	Regimen B	1,064
Overall Study	NOT COMPLETED	Regimen A	34
Overall Study	NOT COMPLETED	Regimen B	269

Source ClinicalTrials.gov

Adverse events1,030

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	22	112	47
other	Anemia	Blood and lymphatic system disorders	Regimen B	428	1,328	962
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Regimen A	1	112	1
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Regimen B	16	1,328	24
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Regimen A	0	112	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Regimen B	3	1,328	3
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen A	0	112	0
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen B	19	1,328	23
other	Hemolytic uremic syndrome	Blood and lymphatic system disorders	Regimen A	0	112	0
other	Hemolytic uremic syndrome	Blood and lymphatic system disorders	Regimen B	1	1,328	1

1 to 10 of 1,030Source ClinicalTrials.gov

See all 1,030 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen A
Total, all-cause mortality	Regimen B
Total, other adverse events	Regimen A	92	112
Total, other adverse events	Regimen B	1,244	1,328
Total, serious adverse events	Regimen A	10	112
Total, serious adverse events	Regimen B	785	1,328

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20879881	DERIVED	PubMed
35839426	DERIVED	PubMed
37883734	DERIVED	PubMed

Grants3

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	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER
U10CA030969	PEDIATRIC ONCOLOGY GROUP	REAMAN, GREGORY H	NATIONAL CHILDHOOD CANCER FOUNDATION	NATIONAL CANCER INSTITUTE	1985 to 2002	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Regimen A vs Regimen B: serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00026312

GET https://conductscience.org/api/trials/v1/NCT00026312/events?page=2

API reference For AI assistants