Trial · NCT00066365

Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

NCT00066365, Phase 2, Completed, Children's Oncology Group; results first posted 2015-03-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma. Trials, record NCT00066365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066365

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Trial

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

Title: Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
NCT number: NCT00066365
Status: Completed
Phases: Phase 2
Enrollment: 49 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Metastatic Cancer, Sarcoma
Interventions: sargramostim, conventional surgery
First posted: 2003-08-07
Last updated: 2015-03-30
Results first posted: 2015-03-30

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Status of FAS Ligand in Pre-chemotherapy Sample	29 days after start of protocol therapy	FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Primary	Presence of FAS in Pre-chemotherapy Sample	29 days after start of protocol therapy	FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Primary	FAS Ligand in Post Chemotherapy Sample	29 days after start of protocol therapy	FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.
Primary	FAS Status in Post Chemotherapy Sample	29 days after start of protocol therapy	FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Primary	CD1a Status in Pre Chemotherapy Sample	29 days after start of protocol therapy	CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Primary	CD1a Status in Post Chemotherapy Sample	29 days after start of protocol therapy	CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Primary	S100 Status in Pre Chemotherapy Sample	29 days after start of protocol therapy	The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Primary	S100 Status in Post Chemotherapy Sample	29 days after start of protocol therapy	The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Primary	Clusterin Status in Pre Chemotherapy Sample	29 days after start of protocol therapy	The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.
Primary	Clusterin Status in Post Chemotherapy Sample	29 days after start of protocol therapy

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Status of FAS Ligand in Pre-chemotherapy Sample	29 days after start of protocol therapy	Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.	participants	NUMBER
PRIMARY	Presence of FAS in Pre-chemotherapy Sample	29 days after start of protocol therapy	Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.	participants	NUMBER
PRIMARY	FAS Ligand in Post Chemotherapy Sample	29 days after start of protocol therapy	22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.	participants	NUMBER
PRIMARY	FAS Status in Post Chemotherapy Sample	29 days after start of protocol therapy	22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.	participants	NUMBER
PRIMARY	CD1a Status in Pre Chemotherapy Sample	29 days after start of protocol therapy	Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.	participants	NUMBER
PRIMARY	CD1a Status in Post Chemotherapy Sample	29 days after start of protocol therapy	20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.	participants	NUMBER
PRIMARY	S100 Status in Pre Chemotherapy Sample	29 days after start of protocol therapy	Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.	participants	NUMBER
PRIMARY	S100 Status in Post Chemotherapy Sample	29 days after start of protocol therapy	20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.	participants	NUMBER
PRIMARY	Clusterin Status in Pre Chemotherapy Sample	29 days after start of protocol therapy	Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.	participants	NUMBER
PRIMARY	Clusterin Status in Post Chemotherapy Sample	29 days after start of protocol therapy	This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.	participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

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

Outcome	Group	Category	Value	Units
Status of FAS Ligand in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 0	7	participants
Status of FAS Ligand in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 1	5	participants
Status of FAS Ligand in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 2	1	participants
Status of FAS Ligand in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 3	1	participants
Presence of FAS in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 0	5	participants
Presence of FAS in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 1	5	participants
Presence of FAS in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 2	2	participants
Presence of FAS in Pre-chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 3	2	participants
FAS Ligand in Post Chemotherapy Sample	Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 0	16	participants
FAS Ligand in Post Chemotherapy Sample	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	IHC Category 0	7	participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy	31
Overall Study	STARTED	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	18
Overall Study	COMPLETED	Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy	8
Overall Study	COMPLETED	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	4
Overall Study	NOT COMPLETED	Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy	23
Overall Study	NOT COMPLETED	Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy	14

Source ClinicalTrials.gov

Adverse events70

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
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Group 1 (Unilateral Recurrence)	1	27
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Group 2 (Bilateral Recurrence)	0	16
other	Anemia	Blood and lymphatic system disorders	Group 1 (Unilateral Recurrence)	1	27
other	Anemia	Blood and lymphatic system disorders	Group 2 (Bilateral Recurrence)	0	16
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Group 1 (Unilateral Recurrence)	1	27
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Group 2 (Bilateral Recurrence)	0	16
other	Bronchospasm	Respiratory, thoracic and mediastinal disorders	Group 1 (Unilateral Recurrence)	1	27
other	Bronchospasm	Respiratory, thoracic and mediastinal disorders	Group 2 (Bilateral Recurrence)	0	16
other	Cough	Respiratory, thoracic and mediastinal disorders	Group 1 (Unilateral Recurrence)	2	27
other	Cough	Respiratory, thoracic and mediastinal disorders	Group 2 (Bilateral Recurrence)	0	16

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1 (Unilateral Recurrence)
Total, all-cause mortality	Group 2 (Bilateral Recurrence)
Total, other adverse events	Group 1 (Unilateral Recurrence)	8	27
Total, other adverse events	Group 2 (Bilateral Recurrence)	4	16
Total, serious adverse events	Group 1 (Unilateral Recurrence)	4	27
Total, serious adverse events	Group 2 (Bilateral Recurrence)	0	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20576718	RESULT

Source PubMed

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 comparisons1

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

Comparison
Group 1 (Unilateral Recurrence) vs Group 2 (Bilateral Recurrence): 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/NCT00066365

GET https://conductscience.org/api/trials/v1/NCT00066365/results?page=2

API reference For AI assistants