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Trial record 6 of 12 for:    "Wilms Tumor 1" | "Hormones"

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

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ClinicalTrials.gov Identifier: NCT00309907
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : February 14, 2014
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description

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

Period Title: Overall Study
Started 39
Completed 19
Not Completed 20
Reason Not Completed
Death             4
Physician Decision             1
Ineligible             11
Major infectious event             4
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description

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

Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
11
(1 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
19
  48.7%
Male
20
  51.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
American Indian or Alaska Native
1
   2.6%
Asian
5
  12.8%
Native Hawaiian or Other Pacific Islander
1
   2.6%
Black or African American
5
  12.8%
White
22
  56.4%
More than one race
0
   0.0%
Unknown or Not Reported
5
  12.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Hispanic or Latino
6
  15.4%
Not Hispanic or Latino
33
  84.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants
United States 35
Canada 2
Sri Lanka 1
Saudi Arabia 1
1.Primary Outcome
Title Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
Hide Description 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.
Time Frame At day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
With Response 20
Without Response 8
2.Secondary Outcome
Title Survival Rate
Hide Description Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.
Time Frame Up to day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description:
Regimen A
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75
(55 to 87)
3.Secondary Outcome
Title Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
Hide Description Pulmonary response is defined as alive & come off of oxygen .
Time Frame up to day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 28 patients are evaluable for this outcome.
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description:
Regimen A
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of participants
74
4.Secondary Outcome
Title Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
Hide Description Grade 3-5 organ toxicities attributable to etanercept.
Time Frame Up to 56 days
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Hide Analysis Population Description
28 patients evaluable for this outcome.
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description:
Regimen A
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: Patients
0
5.Secondary Outcome
Title Plasma Cytokine IL6 Level
Hide Description Estimated mean and standard error of IL6 level
Time Frame From baseline to days 7 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description:
Regimen A
Overall Number of Participants Analyzed 26
Mean (Standard Error)
Unit of Measure: pg/ml
Baseline 205.2  (58)
Day 7 28.8  (4.4)
Day 28 23.1  (3.5)
6.Secondary Outcome
Title C-reactive Protein Levels
Hide Description Estimated mean and standard deviation
Time Frame From baseline to days 7, 14, 21, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description:
Regimen A
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 24 participants
28.1  (59.1)
Day 7 Non Responders Number Analyzed 12 participants
5.4  (11.4)
Day 7 Responders Number Analyzed 10 participants
1.8  (1.9)
Day 14 Non Responders Number Analyzed 10 participants
4.9  (11.1)
Day 14 Responders Number Analyzed 8 participants
1  (1.1)
Day 21 Non Responders Number Analyzed 7 participants
10.7  (14.3)
Day 21 Responders Number Analyzed 12 participants
1.6  (2.4)
Day 28 Non Responders Number Analyzed 5 participants
19.6  (29.7)
Day 28 Responders Number Analyzed 14 participants
5.3  (16.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Eleven ineligible patients are not reported in the adverse events.
 
Arm/Group Title Etanercept and Corticosteroid Therapy
Hide Arm/Group Description

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

All-Cause Mortality
Etanercept and Corticosteroid Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept and Corticosteroid Therapy
Affected / at Risk (%)
Total   5/28 (17.86%) 
Cardiac disorders   
Ventricular arrhythmia  1/28 (3.57%) 
Gastrointestinal disorders   
Esophageal hemorrhage  1/28 (3.57%) 
General disorders   
Death NOS  1/28 (3.57%) 
Multi-organ failure  1/28 (3.57%) 
Infections and infestations   
Infections and infestations - Other, specify  1/28 (3.57%) 
Upper respiratory infection  1/28 (3.57%) 
Investigations   
Blood bilirubin increased  1/28 (3.57%) 
Metabolism and nutrition disorders   
Alkalosis  1/28 (3.57%) 
Hyperglycemia  1/28 (3.57%) 
Nervous system disorders   
Nervous system disorders - Other, specify  1/28 (3.57%) 
Peripheral motor neuropathy  1/28 (3.57%) 
Renal and urinary disorders   
Acute kidney injury  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1/28 (3.57%) 
Hypoxia  2/28 (7.14%) 
Pleural effusion  1/28 (3.57%) 
Pneumonitis  1/28 (3.57%) 
Pneumothorax  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1/28 (3.57%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept and Corticosteroid Therapy
Affected / at Risk (%)
Total   6/28 (21.43%) 
Gastrointestinal disorders   
Ascites  1/28 (3.57%) 
Hepatobiliary disorders   
Hepatic failure  1/28 (3.57%) 
Infections and infestations   
Enterocolitis infectious  1/28 (3.57%) 
Infections and infestations - Other, specify  1/28 (3.57%) 
Investigations   
Creatinine increased  1/28 (3.57%) 
Neutrophil count decreased  1/28 (3.57%) 
Platelet count decreased  1/28 (3.57%) 
White blood cell decreased  2/28 (7.14%) 
Metabolism and nutrition disorders   
Hyperglycemia  1/28 (3.57%) 
Hypokalemia  1/28 (3.57%) 
Renal and urinary disorders   
Acute kidney injury  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1/28 (3.57%) 
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
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0567
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00309907     History of Changes
Other Study ID Numbers: ASCT0521
NCI-2009-00429 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-PBMTC-SUP051 ( Other Identifier: Children's Oncology Group )
COG-ASCT0521 ( Other Identifier: Children's Oncology Group )
CDR0000456407 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 29, 2006
First Posted: April 3, 2006
Results First Submitted: January 6, 2014
Results First Posted: February 14, 2014
Last Update Posted: September 29, 2017