Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant

Completed · Phase 2

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Disseminated Neuroblastoma, Juvenile Myelomonocytic Leukemia, Previously Treated Childhood Rhabdomyosarcoma, Previously Treated Myelodysplastic Syndromes, Pulmonary Complications, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Neuroblastoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID: NCT00309907
Run by: Children's Oncology Group
People needed: 39
Starts: 2006-04-01
Expected to finish: 2011-09-01
Last updated by the study team: 2017-09-29

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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
Evidence of bilateral pulmonary infiltrates (on chest radiograph)
Patients may have diffuse alveolar hemorrhage (DAH) or peri-engraftment respiratory distress syndrome (PERDS)
Presence of "mixed oral flora," "rare Candida species," or the presence of a Penicillium species reported on BAL fluid analysis allowed
A radiographic finding of pulmonary edema does not exclude the diagnosis of IPS, provided the other criteria have been met and provided the treating physician concludes by clinical (or echocardiographic) criteria that the pulmonary edema is not secondary to cardiac dysfunction or iatrogenic fluid overload
Patients must require supplemental oxygen
Must have undergone an allogeneic bone marrow, cord blood, or peripheral blood stem cell transplantation within the past 120 days
There are no restrictions based upon underlying disease, donor source, the degree of HLA match, the intensity of the pre-transplant conditioning regimen, or the use of a prior donor leukocyte infusion
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

Where it is running

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
All Children's Hospital — St. Petersburg, Florida, United States
Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
Childrens Memorial Hospital — Chicago, Illinois, United States
Indiana University Cancer Center — Indianapolis, Indiana, United States
Indiana University Medical Center — Indianapolis, Indiana, United States
Children's Hospital-Main Campus — New Orleans, Louisiana, United States
Johns Hopkins University — Baltimore, Maryland, United States
C S Mott Children's Hospital — Ann Arbor, Michigan, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Columbia University Medical Center — New York, New York, United States
New York Medical College — Valhalla, New York, United States
Oregon Health and Science University — Portland, Oregon, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Cook Children's Medical Center — Fort Worth, Texas, United States
Methodist Children's Hospital of South Texas — San Antonio, Texas, United States
Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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