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Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on May 04, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Respiratory Distress Syndrome, Adult; Bronchiolitis Obliterans; Pneumonia

Intervention: etanercept (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: FDA Office of Orphan Products Development

Official(s) and/or principal investigator(s):
Kenneth Cooke, M.D., Principal Investigator, Affiliation: University of Michigan, Ann Arbor, MI

Summary

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.

Clinical Details

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

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study

Detailed description: 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

Minimum age: 12 Months. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Michigan, Ann Arbor, Michigan 48109, United States
Additional Information

Starting date: September 2001
Ending date: September 2003
Last updated: January 31, 2006

Page last updated: May 04, 2007

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