Research

Idiopathic Pneumonia Syndrome Treatment with Enbrel® - Phase II

Soluble Tumor Necrosis Factor Receptor: Enbrel® for the Treatment of Acute Non-Infectious Pulmonary Dysfunction following Allogeneic Stem Cell Transplantation

Protocol Description

The purpose of this Children's Oncology Group study is to determine whether the experimental drug etanercept, also known by the trade name Enbrel®, is a drug of recourse for patients suffering from idiopathic pneumonia syndrome (IPS) after undergoing stem cell transplant. Recent studies show that the lung fluid of patients with IPS contains higher than normal amounts of certain proteins that may directly damage the lung. One of these proteins, called tumor necrosis factor (TNF) may also be involved in lung injury from IPS. In this Phase II study, Etanercept will be administered to potentially block the damaging effects of TNF, possibly improving a patient’s ability to breathe. This multi-centered study will enroll between 15 and 40 male and female patients.

Eligibility Criteria

Participants that have been diagnosed with idiopathic pneumonia syndrome (IPS) and who are between the ages of 1 and 18 years will be asked to participate.

Boys: 1 to 18 years
Girls: 1 to 18 years

Requirements
Participants will undergo a medical exam, which will include a chest X-ray, blood tests and a bronchoscopy procedure. Throughout the study, 8 doses of etanercept will be administered, along with corticosteroids as part of study therapy. After seven days, the corticosteroid dose will be decreased as medically indicated.

Visits: 8
Duration: 8 weeks

Status: Open for Enrollment

Source of Support
Children’s Oncology Group (Study ASCT0521)
Pediatric Blood and Marrow Transplant Consortium (Study SUP051)
National Cancer Institute (NCI)
Amgen, Inc.

Additional Resources
Leukemia
Bone Marrow Transplant
Study description at National Institutes of Health