Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation - Full Text View

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Masking: 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

Resource links provided by NLM:

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

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 (Child, Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

FDA Office of Orphan Products Development

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00029328 History of Changes
Other Study ID Numbers:	FD-R-2020-01 UMCC-0078; FD-R-002020-01
Study First Received:	January 10, 2002
Last Updated:	March 24, 2015

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:


Syndrome Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Bronchiolitis Bronchiolitis Obliterans Acute Lung Injury Disease Pathologic Processes 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

ClinicalTrials.gov processed this record on July 21, 2017