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NCT00309907 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-09-29

This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

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outcome · POSTED

Survival Rate

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outcome · POSTED

Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy

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outcome · POSTED

Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0

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outcome · POSTED

Plasma Cytokine IL6 Level

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outcome · POSTED

C-reactive Protein Levels

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Diagnosis of acute, noninfectious idiopathic pulmonary dysfunction (IPS) as defined by the following: * Evidence of diffuse lung injury occurring within the first several months after hematopoietic stem cell transplantation for which an infectious etiology is not identified. To meet the criteria for IPS there must be: * Evidence of widespread alveolar injury * Diffuse multi-lobar infiltrates on chest x-ray or CT scan * Evidence for abnormal respiratory physiology based upon 1 of the following: * Room air oxygen saturation \< 93% * Supplemental oxygen required to maintain an oxygen saturation ≥ 93% * Absence of active lower respiratory tract infection, defined as Bronchoalveolar lavage (BAL)-negative for infection based on one of the following: * Gram stain, fungal stain, acid-fast bacilli stain * Bacterial culture (a quantitative culture ≥ 10\^4 colony-forming units/mL is considered positive) * Fungal culture * Mycobacterial culture * Viral culture (respiratory syncytial virus \[RSV\], parainfluenza, adenovirus, influenza A and B, and cytomegalovirus \[CMV\]) * If direct fluorescent antibody (DFA) screening is performed on BAL, it must be negative for all viruses listed above * Pneumocystis carinii pneumonia by polymerase chain reaction (PCR), DFA stain, or cytology * Evidence of bilateral pulmonary infiltrates (on chest radiograph) * Patients may have diffuse alveolar hemorrhage (DAH) or peri-engraftment respiratory distress syndrome (PERDS) * Presence of "mixed oral flora," "rare Candida species," or the presence of a Penicillium species reported on BAL fluid analysis allowed * A radiographic finding of pulmonary edema does not exclude the diagnosis of IPS, provided the other criteria have been met and provided the treating physician concludes by clinical (or echocardiographic) criteria that the pulmonary edema is not secondary to cardiac dysfunction or iatrogenic fluid overload * Patients must require supplemental oxygen * Must have undergone an allogeneic bone marrow, cord blood, or peripheral blood stem cell transplantation within the past 120 days * There are no restrictions based upon underlying disease, donor source, the degree of HLA match, the intensity of the pre-transplant conditioning regimen, or the use of a prior donor leukocyte infusion * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No documented invasive fungal or systemic viral infection within the past 14 days * Patients with asymptomatic viruria allowed * No signs of CMV reactivation (by CMV, PCR, antigenemia, or shell vial culture) within the past 14 days * No sepsis syndrome or hypotension that requires inotropic support (except dopamine \< 5mcg/kg/minute) * No documented bacteremia within the past 48 hours * Persistent fever allowed * No evidence of cardiac failure by clinical or echocardiographic findings * No known hypersensitivity to etanercept * No known history of tuberculosis (Tb) or prior Tb exposure * No prior chronic hepatitis B or hepatitis C infection * Concurrent treatment for acute or chronic GVHD allowed * More than 14 days since prior etanercept * More than 7 days since prior investigational drug trials (phase I, II, or III) for the treatment of acute graft-versus-host disease (GVHD) * Not on mechanical ventilation for \> 48 continuous hours prior to study entry * Must not be receiving \> 2 mg/kg/day of methylprednisolone or corticosteroid equivalent within 24 hours of study entry * Concurrent continuous veno-venous hemofiltration or hemodialysis allowed
healthy Volunteers
false
maximum Age
17 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Biological: etanercept
    2. Drug: methylprednisolone
    label
    Etanercept and corticosteroid therapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Etanercept and corticosteroid therapy
    description
    Given IV and subcutaneously
    name
    etanercept
    other Names
    1. Enbrel
    2. ETN
    3. TNFR:Fc
    4. Tumor Necrosis Factor Receptor IgG Chimera
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Etanercept and corticosteroid therapy
    description
    Given IV and orally
    name
    methylprednisolone
    other Names
    1. Depo-Medrol
    2. Medrol
    3. MePRDL
    4. Solu-Medrol
    5. Wyacort
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
39
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
    time Frame
    At day 28
secondary Outcomes
  1. description
    Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.
    measure
    Survival Rate
    time Frame
    Up to day 56
  2. description
    Pulmonary response is defined as alive \& come off of oxygen .
    measure
    Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
    time Frame
    up to day 56
  3. description
    Grade 3-5 organ toxicities attributable to etanercept.
    measure
    Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
    time Frame
    Up to 56 days
  4. description
    Estimated mean and standard error of IL6 level
    measure
    Plasma Cytokine IL6 Level
    time Frame
    From baseline to days 7 and 28
  5. description
    Estimated mean and standard deviation
    measure
    C-reactive Protein Levels
    time Frame
    From baseline to days 7, 14, 21, and 28
Full study description
brief Summary
This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant.
detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate, defined as survival and complete discontinuation of supplemental oxygen at day 28, in pediatric patients with acute noninfectious pulmonary dysfunction (idiopathic pneumonia syndrome \[IPS\]) after undergoing allogeneic stem cell transplantation treated with etanercept. SECONDARY OBJECTIVES: I. Estimate the day 56 survival rate in patients treated with this drug. II. Determine the overall survival distribution in patients treated with this drug. III. Determine the pulmonary response, as defined as the time to discontinuation of supplemental oxygen, in patients treated with this drug. IV. Evaluate the toxicity of etanercept therapy in patients with IPS. V. Evaluate levels of pro-inflammatory cytokines, in both bronchoalveolar lavage (BAL) fluid and serum, in patients with IPS. VI. Describe C-reactive protein (CRP) levels at baseline, day 7, 14, 21, and 28 and their association with response in patients with IPS. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive etanercept IV over 30 minutes on day 0 and subcutaneously 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 on days 0-2 and then orally with a taper until day 56. After completion of study treatment, patients are followed periodically for 5 years.
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    Preserved source evidence · Not medical advice