NCT00309907 · STUDY IN CONTEXT

Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for \> 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.

Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.

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secondary · POSTED

Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.

Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.

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secondary · POSTED

Pulmonary response is defined as alive \& come off of oxygen .

Total of 28 patients are evaluable for this outcome.

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secondary · POSTED

Grade 3-5 organ toxicities attributable to etanercept.

28 patients evaluable for this outcome.

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secondary · POSTED

Estimated mean and standard error of IL6 level

Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.

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secondary · POSTED

Estimated mean and standard deviation

The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id: NCT00309907
trial label: Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0000
source section id
NCT00309907-om-0000
source outcome index
0
endpoint
Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
endpoint definition
Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for \> 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.
time origin
At day 28
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0001
source section id
NCT00309907-om-0001
source outcome index
1
endpoint
Survival Rate
endpoint definition
Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.
time origin
Up to day 56
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0002
source section id
NCT00309907-om-0002
source outcome index
2
endpoint
Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
endpoint definition
Pulmonary response is defined as alive \& come off of oxygen .
time origin
up to day 56
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Total of 28 patients are evaluable for this outcome.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0003
source section id
NCT00309907-om-0003
source outcome index
3
endpoint
Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
endpoint definition
Grade 3-5 organ toxicities attributable to etanercept.
time origin
Up to 56 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
28 patients evaluable for this outcome.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0004
source section id
NCT00309907-om-0004
source outcome index
4
endpoint
Plasma Cytokine IL6 Level
endpoint definition
Estimated mean and standard error of IL6 level
time origin
From baseline to days 7 and 28
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0005
source section id
NCT00309907-om-0005
source outcome index
5
endpoint
C-reactive Protein Levels
endpoint definition
Estimated mean and standard deviation
time origin
From baseline to days 7, 14, 21, and 28
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0000
arm key
OG000
arm label
Etanercept and Corticosteroid Therapy
regimen
Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56. etanercept: Given IV and subcutaneously methylprednisolone: Given IV and orally
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309907-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0001
arm key
OG000
arm label
Etanercept and Corticosteroid Therapy
regimen
Regimen A
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309907-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0002
arm key
OG000
arm label
Etanercept and Corticosteroid Therapy
regimen
Regimen A
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309907-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0003
arm key
OG000
arm label
Etanercept and Corticosteroid Therapy
regimen
Regimen A
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309907-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0004
arm key
OG000
arm label
Etanercept and Corticosteroid Therapy
regimen
Regimen A
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309907-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
outcome key
om-0005
arm key
OG000
arm label
Etanercept and Corticosteroid Therapy
regimen
Regimen A
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309907-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT00309907
harm key
EG000
source section id
NCT00309907-ae
event group key
EG000
event group label
Etanercept and Corticosteroid Therapy
serious affected
5
serious at risk
28
other affected
6
other at risk
28
frequency threshold
0
collection period
Source null
event definition
Eleven ineligible patients are not reported in the adverse events.
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

setting source links

Preserved source evidence · Not medical advice