Respiratory Distress Syndrome, Adult Clinical Trial
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
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | February 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The University of Michigan Cancer Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Cancer Center |
United States,
Yanik GA, Mineishi S, Levine JE, Kitko CL, White ES, Vander Lugt MT, Harris AC, Braun T, Cooke KR. Soluble tumor necrosis factor receptor: enbrel (etanercept) for subacute pulmonary dysfunction following allogeneic stem cell transplantation. Biol Blood Ma — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO | 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) . | week 12 post therapy | Yes |
Secondary | Percentage of Participants That Experience Grade 3 to 4 Adverse Events | 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. | continuously (and week 4, week 8 and week 12, week 20) | Yes |
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