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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00309907
First received: March 29, 2006
Last updated: February 14, 2014
Last verified: February 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: 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
Interventions: Biological: etanercept
Drug: methylprednisolone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

etanercept: Given IV and subcutaneously

methylprednisolone: Given IV and orally


Participant Flow:   Overall Study
    Etanercept and Corticosteroid Therapy  
STARTED     39  
COMPLETED     19  
NOT COMPLETED     20  
Death                 4  
Physician Decision                 1  
Ineligible                 11  
Major infectious event                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

etanercept: Given IV and subcutaneously

methylprednisolone: Given IV and orally


Baseline Measures
    Etanercept and Corticosteroid Therapy  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Median ( Full Range )
  11  
  ( 1 to 17 )  
Gender  
[units: participants]
 
Female     19  
Male     20  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     5  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     5  
White     22  
More than one race     0  
Unknown or Not Reported     5  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     6  
Not Hispanic or Latino     33  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     35  
Canada     2  
Sri Lanka     1  
Saudi Arabia     1  



  Outcome Measures

1.  Primary:   Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.   [ Time Frame: At day 28 ]

2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Discontinuation of Supplemental Oxygen Support   [ Time Frame: Time from study to time on room air, assessed up to 56 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0   [ Time Frame: Up to 56 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   C-reactive Protein Levels   [ Time Frame: From baseline to days 7, 14, 21, and 28 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 352-273-0567
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00309907     History of Changes
Other Study ID Numbers: ASCT0521, NCI-2009-00429, COG-PBMTC-SUP051, COG-ASCT0521, CDR0000456407, U10CA098543
Study First Received: March 29, 2006
Results First Received: January 6, 2014
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board