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Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

This study has been completed.

Sponsored by: FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00029328
  Purpose

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 Intervention Phase
Respiratory Distress Syndrome, Adult
Bronchiolitis Obliterans
Pneumonia
Drug: etanercept
Phase I
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Pneumonia   

Drug Information available for:   Etanercept    Tumor Necrosis Factors   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title:   Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:   15
Study Start Date:   September 2001
Estimated Study Completion Date:   September 2003

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.

  Eligibility
Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029328

Locations
United States, Michigan
University of Michigan    
      Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Investigators
Principal Investigator:     Kenneth Cooke, M.D.     University of Michigan, Ann Arbor, MI    
  More Information


Study ID Numbers:   FD-R-2020-01, UMCC-0078;, FD-R-002020-01
First Received:   January 10, 2002
Last Updated:   January 31, 2006
ClinicalTrials.gov Identifier:   NCT00029328
Health Authority:   United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
TNFR-Fc fusion protein  
Stem Cell Transplantation  
Transplantation, Homologous  
Respiratory Function Tests  

Study placed in the following topic categories:
Lung Diseases, Interstitial
Bronchiolitis
Respiratory Distress Syndrome, Adult
Respiration Disorders
TNFR-Fc fusion protein
Bronchiolitis Obliterans
Necrosis
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Bronchitis
Acute respiratory distress syndrome
Pneumonia

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Disease
Immunologic Factors
Bronchial Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on December 03, 2008




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