Text Size

Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00029328
First received: January 10, 2002
Last updated: January 31, 2006
Last verified: November 2001
History of Changes

January 10, 2002
January 31, 2006
September 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00029328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Distress Syndrome, Adult
  • Bronchiolitis Obliterans
  • Pneumonia
Drug: etanercept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2003
Not Provided

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
Both
12 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029328
FD-R-2020-01, UMCC-0078;, FD-R-002020-01
Not Provided
Not Provided
FDA Office of Orphan Products Development
Not Provided
Principal Investigator: Kenneth Cooke, M.D. University of Michigan, Ann Arbor, MI
FDA Office of Orphan Products Development
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP