Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
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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.
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.
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Ages Eligible for Study:
12 Months and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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