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Etanercept

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etanercept

Kenneth Cooke, M.D.

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.

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.

Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

FDA Office of Orphan Products Development

Thoracic Injuries

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.

Gregory A Yanik, MD

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 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.

Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study

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) .

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.

University of Michigan Rogel Cancer Center

Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.

Etanercept for lung injury

Etanercept: 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.

Etanercept Treatment

Age, Continuous

Sex: Female, Male

AML/MDS/MF

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Chronic Graft Versus Host Disease (GVHD) Present

Restrictive

Obstructive

Lung Injury Pattern

All patients enrolled that received at least one scheduled dose.

Gregory Yanik, M.D.

≥10% Improvement in FEV1 / FVC

≥10% Improvement in DLCO

34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing \<50% of scheduled dosing.

Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation	NCT00029328	Respiratory Dis... Bronchiolitis O... Pneumonia	etanercept	12 Months -	FDA Office of Orphan Products Development
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant	NCT00141726	Lung Injury, Ac... Respiratory Dis... Bronchiolitis O...	Etanercept	6 Years -	University of Michigan Rogel Cancer Center

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