Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Detailed Description
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Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

Official Title
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Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

Conditions
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Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans, Pneumonia

Intervention / Treatment
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* Drug: etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury At least 1 year of age for IPS stratum At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing At least 14 days since prior treatment with an investigational drug for graft-versus-host disease Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease Exclusion criteria: Documented evidence of active systemic or pulmonary infection Cardiogenic failure as cause of pulmonary dysfunction Known hypersensitivity to etanercept Currently receiving dialysis Currently receiving inotropic medications except dopamine Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: etanercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TNFR-Fc fusion protein, Stem Cell Transplantation, Transplantation, Homologous, Respiratory Function Tests