This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant.
PRIMARY OBJECTIVES: I. Determine the response rate, defined as survival and complete discontinuation of supplemental oxygen at day 28, in pediatric patients with acute noninfectious pulmonary dysfunction (idiopathic pneumonia syndrome \[IPS\]) after undergoing allogeneic stem cell transplantation treated with etanercept. SECONDARY OBJECTIVES: I. Estimate the day 56 survival rate in patients treated with this drug. II. Determine the overall survival distribution in patients treated with this drug. III. Determine the pulmonary response, as defined as the time to discontinuation of supplemental oxygen, in patients treated with this drug. IV. Evaluate the toxicity of etanercept therapy in patients with IPS. V. Evaluate levels of pro-inflammatory cytokines, in both bronchoalveolar lavage (BAL) fluid and serum, in patients with IPS. VI. Describe C-reactive protein (CRP) levels at baseline, day 7, 14, 21, and 28 and their association with response in patients with IPS. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive etanercept IV over 30 minutes on day 0 and subcutaneously on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV on days 0-2 and then orally with a taper until day 56. After completion of study treatment, patients are followed periodically for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Given IV and subcutaneously
Given IV and orally
University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Oncology Group
Arcadia, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for \> 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.
Time frame: At day 28
Survival Rate
Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.
Time frame: Up to day 56
Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
Pulmonary response is defined as alive \& come off of oxygen .
Time frame: up to day 56
Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
Grade 3-5 organ toxicities attributable to etanercept.
Time frame: Up to 56 days
Plasma Cytokine IL6 Level
Estimated mean and standard error of IL6 level
Time frame: From baseline to days 7 and 28
C-reactive Protein Levels
Estimated mean and standard deviation
Time frame: From baseline to days 7, 14, 21, and 28
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