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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): etanercept; methylprednisolone
Intervention type(s): Biological; Drug
Intervention description(s): Given IV and subcutaneously; Given IV and orally
Other intervention name(s): Enbrel; ETN; TNFR:Fc; Tumor Necrosis Factor Receptor IgG Chimera; Depo-Medrol; Medrol; MePRDL; Solu-Medrol; Wyacort
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Etanercept; Prednisolone hemisuccinate; Prednisolone phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment