Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029328
• Other study ID #: FD-R-2020-01
• Secondary ID: UMCC-0078;FD-R-0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 10, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: September 2003

Study information

• Verified date: November 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Bronchiolitis
• Bronchiolitis Obliterans
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• etanercept

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

Country where clinical trial is conducted

United States,