Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
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
Juvenile Myelomonocytic Leukemia
Previously Treated Childhood Rhabdomyosarcoma
Previously Treated Myelodysplastic Syndromes
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 Wilms Tumor and Other Childhood Kidney Tumors
Recurrent/Refractory Childhood Hodgkin Lymphoma
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation|
- Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28. [ Time Frame: At day 28 ] [ Designated as safety issue: No ]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.
- Survival Rate [ Time Frame: From the first dose of treatment with etanercept to the date of last follow up or date of death, assessed up to 56 days ] [ Designated as safety issue: No ]
- Time to Discontinuation of Supplemental Oxygen Support [ Time Frame: Time from study to time on room air, assessed up to 56 days ] [ Designated as safety issue: No ]The "time required to discontinue supplemental oxygen" will be measured in the number of days from study entry till the patient is on room air and will be estimated using the cumulative incidence estimator due to the competing risk of death.
- Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0 [ Time Frame: Up to 56 days ] [ Designated as safety issue: Yes ]
- Levels of Pro-inflammatory Cytokines, in Both BAL (Bronchoalveolar Lavage) Fluid and Serum as Assessed by Enzyme-linked Immunosorbent Assays [ Time Frame: From baseline to days 7 and 56 ] [ Designated as safety issue: No ]Measurements will be summarized with means and standard deviations for subgroups of subjects (e.g. responders versus non-responders). Two-group comparisons of cytokines (e.g. responders versus non-responders) will likely be underpowered, and such comparisons will be done only to generate hypotheses for future studies. Comparative plasma cytokine assays will be performed in a similar fashion as that of the BAL fluid.
- C-reactive Protein Levels [ Time Frame: From baseline to days 7, 14, 21, and 28 ] [ Designated as safety issue: No ]Measurements will be summarized with mean and standard deviations for subgroups of subjects (those who respond versus non-responders). Two group comparisons of CRP (C-reactive protein) levels (responders versus non-responders) will likely be underpowered, and such comparisons will be done to generate hypotheses for future studies.
|Study Start Date:||April 2006|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Etanercept and corticosteroid therapy
Patients 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.
Given IV and subcutaneously
Other Names:Drug: methylprednisolone
Given IV and orally
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309907
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|Principal Investigator:||Gregory Yanik, MD||Children's Oncology Group|