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Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans Pneumonia |
Drug: etanercept |
Phase I Phase II |
MedlinePlus related topics: Bronchitis; Pneumonia; Respiratory Diseases; Respiratory Syncytial Virus Infections
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
Expected Total Enrollment: 15
Study start: September 2001;
Study completion: September 2003
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.
Eligibility
Ages Eligible for Study: 12 Months and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
Exclusion criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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