Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Treatments: Etanercept

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