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Trial · NCT01183429

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma

NCT01183429, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2019-08-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma. Trials, record NCT01183429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183429

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Trial

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

Title
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma
NCT number
NCT01183429
Status
Completed
Phases
Phase 2
Enrollment
39 participants, actual
Lead sponsor
Memorial Sloan Kettering Cancer Center
Conditions
Neuroblastoma
Interventions
3F8 and 13-cis-retinoic acid
First posted
2010-08-17
Last updated
2019-08-13
Results first posted
2019-08-13

Source ClinicalTrials.gov

Registered outcomes3

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

ListOutcomeTime frameDescription
PrimaryAssess the Impact of High-dose 3F8/GM-CSF2 yearson relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.
SecondaryApply Real-time Quantitative RT-PCR2 yearsto test the hypothesis that the minimal residual disease content of bone marrow after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.
SecondaryMonitor Safety of the High-dose Antibody Treatment2 yearsto assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAssess the Impact of High-dose 3F8/GM-CSF2 yearsNo data were collected
SECONDARYApply Real-time Quantitative RT-PCR2 yearsNo data were collected
SECONDARYMonitor Safety of the High-dose Antibody Treatment2 yearsNo data were collected

Results by group0

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

None in this release.

Participant flow3

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED3F8 and 13-cis-retinoic Acid39
Overall StudyCOMPLETED3F8 and 13-cis-retinoic Acid39
Overall StudyNOT COMPLETED3F8 and 13-cis-retinoic Acid0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality3F8 and 13-cis-retinoic Acid00
Total, other adverse events3F8 and 13-cis-retinoic Acid00
Total, serious adverse events3F8 and 13-cis-retinoic Acid00

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
23633099DERIVED

Source PubMed

Grants0

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.

None in this release.

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.

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/NCT01183429

GET https://conductscience.org/api/trials/v1/NCT01183429/registered