Trial · NCT02484443

Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

NCT02484443, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma. Trials, record NCT02484443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02484443

On this page

Trial

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

Title: Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
NCT number: NCT02484443
Status: Completed
Phases: Phase 2
Enrollment: 41 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Recurrent Osteosarcoma
Interventions: Dinutuximab, Laboratory Biomarker Analysis, Pharmacological Study, Sargramostim
First posted: 2015-06-29
Last updated: 2023-10-26
Results first posted: 2021-05-07

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Disease Control	12 months after study enrollment	Patients who can be confirmed to be free of detectable disease 12 months after enrollment, without intervening disease progression, will be considered to have demonstrated 12 month disease control. All other eligible patients will be considered not to have demonstrated 12 month disease control.
Secondary	T 1/2 Alpha of the Serum Concentration of Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	T 1/2 alpha of the serum concentration of dinutuximab in days
Secondary	T 1/2 Beta of the Serum Concentration of Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	T 1/2 beta of the serum concentration of dinutuximab in days
Secondary	Maximum of Concentration (Cmax) of the Serum Concentration Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	Cmax of the serum concentration dinutuximab as mg/L.
Secondary	Area Under the Curve (AUC)0 to Infinity of Serum Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	(AUC)0 to infinity of serum dinutuximab in mg-h/L.
Secondary	Number of Cycles Where an Unacceptable Toxicity as Defined in the Protocol Using The National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Was Observed	5 cycles of protocol therapy planned as 140 days	The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Occurrence of unacceptable toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, coded as present or absent, in each cycle received by eligible patients where all prescribed therapy for the cycle is received or the patient experiences unacceptable toxicity.
Other	Tumor GD2 Expression	At study enrollment	Archival tumor tissue will be assessed by immunohistochemistry to provide the level of GD2 expression in tissue as an integer between 0 and 3 with 0 indicating no GD2 expression and 3 indicating strong GD2 expression.
Other	KIR Genotype Analyses	At enrollment	KIR mismatch will be assessed from the pre-treatment blood specimen as present or absent.
Other	NKp30c Genotype Analyses	At enrollment	Status of the immunosuppressive isoform of NKp30c KIR mismatch will be assessed from the pre-treatment blood specimen as present or absent.
Other	FcgammaR Genotype Analyses	At enrollment	FcgammaR genotype will be assessed from the pre-treatment blood specimen as H/R, R/R or H/H.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Control	12 months after study enrollment	All eligible patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	T 1/2 Alpha of the Serum Concentration of Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis.	days	MEDIAN
SECONDARY	T 1/2 Beta of the Serum Concentration of Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis.	days	MEDIAN
SECONDARY	Maximum of Concentration (Cmax) of the Serum Concentration Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis.	mg/L	MEDIAN
SECONDARY	Area Under the Curve (AUC)0 to Infinity of Serum Dinutuximab	Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1	Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis.	mg-h/L	MEDIAN
SECONDARY	Number of Cycles Where an Unacceptable Toxicity as Defined in the Protocol Using The National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Was Observed	5 cycles of protocol therapy planned as 140 days	39 patients were treated on protocol therapy. One hundred thirty-six cycles were reported for the analysis of dose limiting toxicity	cycles	NUMBER
OTHER_PRE_SPECIFIED	Tumor GD2 Expression	At study enrollment
OTHER_PRE_SPECIFIED	KIR Genotype Analyses	At enrollment
OTHER_PRE_SPECIFIED	NKp30c Genotype Analyses	At enrollment
OTHER_PRE_SPECIFIED	FcgammaR Genotype Analyses	At enrollment

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group6

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

Outcome	Group	Value	Spread	Units
Disease Control	Treatment (Sargramostim and Dinutuximab)	11		Participants
T 1/2 Alpha of the Serum Concentration of Dinutuximab	Treatment (Sargramostim and Dinutuximab)	0.8	Full Range 0.566 to 1.89	days
T 1/2 Beta of the Serum Concentration of Dinutuximab	Treatment (Sargramostim and Dinutuximab)	7.5	Full Range 7.25 to 7.86	days
Maximum of Concentration (Cmax) of the Serum Concentration Dinutuximab	Treatment (Sargramostim and Dinutuximab)	18.4	Full Range 7.58 to 26.3	mg/L
Area Under the Curve (AUC)0 to Infinity of Serum Dinutuximab	Treatment (Sargramostim and Dinutuximab)	2136	Full Range 904 to 2514	mg-h/L
Number of Cycles Where an Unacceptable Toxicity as Defined in the Protocol Using The National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Was Observed	Treatment (Sargramostim and Dinutuximab)	1		cycles

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Sargramostim and Dinutuximab)	41
Overall Study	COMPLETED	Treatment (Sargramostim and Dinutuximab)	9
Overall Study	NOT COMPLETED	Treatment (Sargramostim and Dinutuximab)	32

Source ClinicalTrials.gov

Adverse events63

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 (Sargramostim and Dinutuximab)	8	39	8
other	Diarrhea	Gastrointestinal disorders	Treatment (Sargramostim and Dinutuximab)	4	39	4
other	Nausea	Gastrointestinal disorders	Treatment (Sargramostim and Dinutuximab)	2	39	2
other	Vomiting	Gastrointestinal disorders	Treatment (Sargramostim and Dinutuximab)	1	39	1
other	Fever	General disorders	Treatment (Sargramostim and Dinutuximab)	2	39	2
other	Non-cardiac chest pain	General disorders	Treatment (Sargramostim and Dinutuximab)	1	39	1
other	Pain	General disorders	Treatment (Sargramostim and Dinutuximab)	7	39	7
other	Allergic reaction	Immune system disorders	Treatment (Sargramostim and Dinutuximab)	5	39	5
other	Cytokine release syndrome	Immune system disorders	Treatment (Sargramostim and Dinutuximab)	1	39	1
other	Serum sickness	Immune system disorders	Treatment (Sargramostim and Dinutuximab)	1	39	1

1 to 10 of 63Source ClinicalTrials.gov

See all 63 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Sargramostim and Dinutuximab)	15	39
Total, other adverse events	Treatment (Sargramostim and Dinutuximab)	28	39
Total, serious adverse events	Treatment (Sargramostim and Dinutuximab)	12	39

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.

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/NCT02484443

GET https://conductscience.org/api/trials/v1/NCT02484443/events?page=2

API reference For AI assistants