Overview

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

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan Cancer Center
University of Michigan Rogel Cancer Center
Treatments:
Etanercept
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.