Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Sponsor

FDA Office of Orphan Products Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00029328

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans Pneumonia	Drug: etanercept	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2001

Study Completion Date :

Sep 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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