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


Phase 1/Phase 2
12 Months
N/A
Not Enrolling
Both
Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans, Pneumonia

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kenneth Cooke, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan, Ann Arbor, MI

Authority:

United States: Food and Drug Administration

Study ID:

FD-R-2020-01

NCT ID:

NCT00029328

Start Date:

September 2001

Completion Date:

September 2003

Related Keywords:

  • Respiratory Distress Syndrome, Adult
  • Bronchiolitis Obliterans
  • Pneumonia
  • TNFR-Fc fusion protein
  • Stem Cell Transplantation
  • Transplantation, Homologous
  • Respiratory Function Tests
  • Bronchiolitis
  • Bronchiolitis Obliterans
  • Pneumonia
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome, Adult
  • Acute Lung Injury

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624