Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
6 other identifiers
interventional
39
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2006
Longer than P75 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
February 14, 2014
CompletedSeptember 29, 2017
February 1, 2017
5.4 years
March 29, 2006
January 6, 2014
September 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At day 28
Secondary Outcomes (5)
Survival Rate
Up to day 56
Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
up to day 56
Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
Up to 56 days
Plasma Cytokine IL6 Level
From baseline to days 7 and 28
C-reactive Protein Levels
From baseline to days 7, 14, 21, and 28
Study Arms (1)
Etanercept and corticosteroid therapy
EXPERIMENTALPatients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) 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 (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.
Interventions
Given IV and subcutaneously
Given IV and orally
Eligibility Criteria
You may qualify if:
- Diagnosis of acute, noninfectious idiopathic pulmonary dysfunction (IPS) as defined by the following:
- Evidence of diffuse lung injury occurring within the first several months after hematopoietic stem cell transplantation for which an infectious etiology is not identified. To meet the criteria for IPS there must be:
- Evidence of widespread alveolar injury
- Diffuse multi-lobar infiltrates on chest x-ray or CT scan
- Evidence for abnormal respiratory physiology based upon 1 of the following:
- Room air oxygen saturation \< 93%
- Supplemental oxygen required to maintain an oxygen saturation ≥ 93%
- Absence of active lower respiratory tract infection, defined as Bronchoalveolar lavage (BAL)-negative for infection based on one of the following:
- Gram stain, fungal stain, acid-fast bacilli stain
- Bacterial culture (a quantitative culture ≥ 10\^4 colony-forming units/mL is considered positive)
- Fungal culture
- Mycobacterial culture
- Viral culture (respiratory syncytial virus \[RSV\], parainfluenza, adenovirus, influenza A and B, and cytomegalovirus \[CMV\])
- If direct fluorescent antibody (DFA) screening is performed on BAL, it must be negative for all viruses listed above
- Pneumocystis carinii pneumonia by polymerase chain reaction (PCR), DFA stain, or cytology
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (26)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Children's Oncology Group
Arcadia, California, 91006-3776, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Children's Hospital-Main Campus
New Orleans, Louisiana, 70118, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York Medical College
Valhalla, New York, 10595, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Yanik, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2006
First Posted
April 3, 2006
Study Start
April 1, 2006
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 29, 2017
Results First Posted
February 14, 2014
Record last verified: 2017-02