Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

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ClinicalTrials.gov Identifier: NCT00029328

Recruitment Status : Completed

First Posted : January 11, 2002

Last Update Posted : March 25, 2015

Sponsor:

Information provided by:

FDA Office of Orphan Products Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans Pneumonia	Drug: etanercept	Phase 1 Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	15 participants
Allocation:	Non-Randomized
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
Study Start Date :	September 2001
Study Completion Date :	September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Drug Information available for: Etanercept

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome Bronchiolitis Obliterans

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Months and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029328

Locations

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

Investigators

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

More Information

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ClinicalTrials.gov Identifier:	NCT00029328
Other Study ID Numbers:	FD-R-2020-01 UMCC-0078; FD-R-002020-01
First Posted:	January 11, 2002 Key Record Dates
Last Update Posted:	March 25, 2015
Last Verified:	November 2001

Keywords provided by FDA Office of Orphan Products Development:


TNFR-Fc fusion protein Stem Cell Transplantation Transplantation, Homologous Respiratory Function Tests

Additional relevant MeSH terms:

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Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Bronchiolitis Bronchiolitis Obliterans Acute Lung Injury Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Bronchitis Bronchial Diseases	Lung Diseases, Obstructive Lung Injury Etanercept Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors

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