Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
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 improved quality of life in these patients.
Lung Injury, Acute
Respiratory Distress Syndrome, Adult
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study|
- Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO [ Time Frame: week 12 post therapy ] [ Designated as safety issue: Yes ]Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .
- Percentage of Participants That Experience Grade 3 to 4 Adverse Events [ Time Frame: continuously (and week 4, week 8 and week 12, week 20) ] [ Designated as safety issue: Yes ]To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.
- To Evaluate the Effect of Etanercept on BAL Fluid and Serum Markers of Pulmonary Inflammation. [ Time Frame: Pre-therapy (w. BAL), week 4, week 8 and week 12 (w. BAL), week 20 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Pre-therapy, week 12, week 20 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Study Completion Date:||February 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: etanercept treatment
Etanercept for lung injury
Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
Other Name: Enbrel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141726
|United States, Michigan|
|The University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Gregory A Yanik, MD||The University of Michigan Comprehensive Cancer Center|