NCT00026312 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only

Eligible, randomized patients.

→

secondary · POSTED

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.

Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.

→

secondary · POSTED

EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.

Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.

→

secondary · POSTED

Proportion of patients experiencing at least one Grade 3 or higher toxicity.

Eligible patients enrolled prior to halting of randomization.

→

secondary · POSTED

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.

Eligible patients assigned to Regimen B, excluding patients with persistent disease.

→

secondary · POSTED

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.

Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Circulating B7-H6 Levels

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-neuroblastoma
nct id: NCT00026312
qol key: qol-0011
source section id: NCT00026312-om-0011
source outcome index: 11
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Circulating B7-H6 Levels
measure definition: Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.
time frame: 1 week before first sargramostim injection (day -1 of course 1)
analysis role: exploratory
reporting status: NOT_POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · NKp30 Isoform Expression and SNP

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-neuroblastoma
nct id: NCT00026312
qol key: qol-0016
source section id: NCT00026312-om-0016
source outcome index: 16
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: NKp30 Isoform Expression and SNP
measure definition: Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.
time frame: 1 week before first sargramostim injection (day -1 of course 1)
analysis role: exploratory
reporting status: NOT_POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-neuroblastoma
nct id: NCT00026312
trial label: Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0000
source section id
NCT00026312-om-0000
source outcome index
0
endpoint
Event-Free Survival (EFS)
endpoint definition
Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only
time origin
Three years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible, randomized patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0001
source section id
NCT00026312-om-0001
source outcome index
1
endpoint
Event-Free Survival (EFS)
endpoint definition
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.
time origin
Three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0002
source section id
NCT00026312-om-0002
source outcome index
2
endpoint
Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial
endpoint definition
EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.
time origin
Three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0003
source section id
NCT00026312-om-0003
source outcome index
3
endpoint
Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0
endpoint definition
Proportion of patients experiencing at least one Grade 3 or higher toxicity.
time origin
From enrollment to follow-up
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients enrolled prior to halting of randomization.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0004
source section id
NCT00026312-om-0004
source outcome index
4
endpoint
Number of Courses of Therapy Delivered
endpoint definition
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.
time origin
Courses 1-6
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients assigned to Regimen B, excluding patients with persistent disease.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0005
source section id
NCT00026312-om-0005
source outcome index
5
endpoint
Overall Survival (OS)
endpoint definition
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.
time origin
Three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0000
arm key
OG000
arm label
Regimen A
regimen
Randomized to Regimen A - RA Only
analyzed count
112
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0000
arm key
OG001
arm label
Regimen B
regimen
Randomized to Regimen B - RA + Immunotherapy
analyzed count
114
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0001
arm key
OG000
arm label
Regimen A
regimen
Randomized to Regimen A - RA Only
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0001
arm key
OG001
arm label
Regimen B
regimen
Regimen B - RA + Immunotherapy
analyzed count
127
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0002
arm key
OG000
arm label
Regimen B
regimen
Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
analyzed count
1177
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0003
arm key
OG000
arm label
Regimen A
regimen
Randomized to Regimen A - RA Only
analyzed count
112
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0003
arm key
OG001
arm label
Regimen B
regimen
Patients that received RA + Immunotherapy before halting of randomization
analyzed count
141
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0004
arm key
OG000
arm label
Regimen B
regimen
Regimen B- RA + Immunotherapy
analyzed count
1291
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0005
arm key
OG000
arm label
Regimen A
regimen
Randomized to Regimen A - RA Only
analyzed count
112
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
outcome key
om-0005
arm key
OG001
arm label
Regimen B
regimen
Randomized to Regimen B - RA + Immunotherapy
analyzed count
114
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00026312-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
harm key
EG000
source section id
NCT00026312-ae
event group key
EG000
event group label
Regimen A
serious affected
10
serious at risk
112
other affected
92
other at risk
112
frequency threshold
0
collection period
Source null
event definition
Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
harm key
EG001
source section id
NCT00026312-ae
event group key
EG001
event group label
Regimen B
serious affected
785
serious at risk
1328
other affected
1244
other at risk
1328
frequency threshold
0
collection period
Source null
event definition
Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
qol key
qol-0011
source section id
NCT00026312-om-0011
source outcome index
11
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Circulating B7-H6 Levels
measure definition
Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.
time frame
1 week before first sargramostim injection (day -1 of course 1)
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00026312
qol key
qol-0016
source section id
NCT00026312-om-0016
source outcome index
16
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
NKp30 Isoform Expression and SNP
measure definition
Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.
time frame
1 week before first sargramostim injection (day -1 of course 1)
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice