The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an imporved quality of life in these patients.

Condition	Intervention	Phase
Lung Injury, Acute Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans	Drug: Etanercept	Phase II

Further Study Details: 

Primary Outcomes: To evaluate the response to etanercept therapy, based upon pulmonary function parameters (FEV1.0, FEV1.0/FVC, DLCO) in patients with sub-acute lung injury > 100 days post transplant
Secondary Outcomes: To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant.; To evaluate the effect of etanercept on BAL fluid and serum markers of pulmonary inflammation.; To examine health related quality of life parameters, including longitudinal changes in and magnitude of persistent disability in patients with sub-acute lung injury post transplant.
Expected Total Enrollment:  25

Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

Ages Eligible for Study:  6 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell transplants are eligible
• Age >6 years and able to complete pulmonary function testing
• Patients with evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or RLD)
• Recipients of sub-ablative transplant regimens are eligible
• Recipients of donor leukocyte infusions (DLI) post-transplant are eligible
• Patients must be > 100 days post transplant

Exclusion Criteria:

• Patients with hypotension requiring inotropic agents other than dopamine < 5mcg/ kg/ minute for blood pressure support.
• Patients with a positive quantitative bacterial culture from the BAL fluid (≥ 104 CFU/ ml is considered positive)
• Patients whose BAL fluid is positive for significant bacterial pathogens or pathogenic nonbacterial microorganisms (as defined by protocol) by special stain, culture or PCR analysis
• Patients who are enrolled on a phase I or phase II trial for the prophylaxis or treatment of GVHD (acute or chronic) within 7 days of study entry.
• Patients with known hypersensitivity to etanercept.
• Patients who are pregnant.
• Patients with CMV seropositivity at the time of study entry. Testing may include wither CMV PCR analysis or CMV pp65 testing.
• Evidence for multi-system organ failure.

Please refer to this study by ClinicalTrials.gov identifier  NCT00141726

Gregory A Yanik, MD      734-936-8785 

Michigan
      The University of Michigan Cancer Center, Ann Arbor,  Michigan,  48109,  United States; Recruiting

Study chairs or principal investigators

Gregory A Yanik, MD,  Principal Investigator,  The University of Michigan Comprehensive Cancer Center   

Study ID Numbers:  UMCC 3-31; IRBMED 2003-0590
Last Updated:  September 1, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141726
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06