Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309907
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2006-03-29
Brief Title:
Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | Clinical Trialsgov | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00429 | REGISTRY | None | None |
| COG-PBMTC-SUP051 | OTHER | None | None |
| COG-ASCT0521 | OTHER | None | None |
| CDR0000456407 | OTHER | None | None |