Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

NCT ID: NCT00029328

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2003-09-30

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.

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.

Conditions

Respiratory Distress Syndrome, Adult; Bronchiolitis Obliterans; Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

etanercept

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FDA Office of Orphan Products Development

FED

Sponsor Role: lead

Principal Investigators

Kenneth Cooke, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Ann Arbor, MI

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC-0078;

Identifier Type: -

Identifier Source: secondary_id

FD-R-002020-01

Identifier Type: -

Identifier Source: secondary_id

FD-R-2020-01

Identifier Type: -

Identifier Source: org_study_id