Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
Condition: 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
MeSH terms: Pneumonia; Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Neoplasm Metastasis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neuroblastoma; Rhabdomyosarcoma; Lymphoma, Non-Hodgkin; Leukemia, Myeloid, Chronic-Phase; Wilms Tumor; Blast Crisis; Leukemia, Myeloid, Accelerated Phase; Rhabdomyosarcoma, Embryonal; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome; Recurrence
Intervention: etanercept; methylprednisolone
Intervention description: Given IV and subcutaneously; Given IV and orally
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Etanercept; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  No documented invasive fungal or systemic viral infection within the past 14 days

               -  Patients with asymptomatic viruria allowed

          -  No signs of CMV reactivation (by CMV, PCR, antigenemia, or shell vial culture) within
             the past 14 days

          -  No sepsis syndrome or hypotension that requires inotropic support (except dopamine <
             5mcg/kg/minute)

          -  No documented bacteremia within the past 48 hours

               -  Persistent fever allowed

          -  No evidence of cardiac failure by clinical or echocardiographic findings

          -  No known hypersensitivity to etanercept

          -  No known history of tuberculosis (Tb) or prior Tb exposure

          -  No prior chronic hepatitis B or hepatitis C infection

          -  Concurrent treatment for acute or chronic GVHD allowed

          -  More than 14 days since prior etanercept

          -  More than 7 days since prior investigational drug trials (phase I, II, or III) for the
             treatment of acute graft-versus-host disease (GVHD)

          -  Not on mechanical ventilation for > 48 continuous hours prior to study entry

          -  Must not be receiving > 2 mg/kg/day of methylprednisolone or corticosteroid equivalent
             within 24 hours of study entry

          -  Concurrent continuous veno-venous hemofiltration or hemodialysis allowed