Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471679
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2007-05-08
Brief Title:
Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among Patients With High-Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2013-03
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:
RATIONALE Ethanol-lock treatment may help prevent central venous catheter infections in patients with high-risk neuroblastoma
PURPOSE This phase I trial is studying the side effects of ethanol-lock treatment in preventing central venous catheter infections in patients with high-risk neuroblastoma
PURPOSE This phase I trial is studying the side effects of ethanol-lock treatment in preventing central venous catheter infections in patients with high-risk neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of the ethanol-lock strategy ETL in preventing central venous catheter infections in patients with high-risk neuroblastoma being treated on clinical trial MSKCC-03077
Secondary
Determine whether this strategy increases the likelihood of remaining infection-free for 6 months
Determine the cumulative incidence of a single positive centrally-drawn blood culture in these patients and compare to previously obtained historical controls
Determine the median time-to-infection of the central line where infection is defined as any positive centrally-drawn from the treated line blood culture
Determine the cumulative incidence of central line removals in these patients and compare to historical controls
Collate the types of organisms among these patients who develop a positive centrally-drawn blood culture and compare to historical controls
OUTLINE This is a prospective nonrandomized open-label historical control study
Patients receive monoclonal antibody 3F8 on clinical trial MSKCC-03077 In each course of monoclonal antibody 3F8 treatment patients receive ethanol-lock treatment on days 0-3 after each monoclonal antibody 3F8 infusion for up to 6 months for central venous catheter management
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the safety and tolerability of the ethanol-lock strategy ETL in preventing central venous catheter infections in patients with high-risk neuroblastoma being treated on clinical trial MSKCC-03077
Secondary
Determine whether this strategy increases the likelihood of remaining infection-free for 6 months
Determine the cumulative incidence of a single positive centrally-drawn blood culture in these patients and compare to previously obtained historical controls
Determine the median time-to-infection of the central line where infection is defined as any positive centrally-drawn from the treated line blood culture
Determine the cumulative incidence of central line removals in these patients and compare to historical controls
Collate the types of organisms among these patients who develop a positive centrally-drawn blood culture and compare to historical controls
OUTLINE This is a prospective nonrandomized open-label historical control study
Patients receive monoclonal antibody 3F8 on clinical trial MSKCC-03077 In each course of monoclonal antibody 3F8 treatment patients receive ethanol-lock treatment on days 0-3 after each monoclonal antibody 3F8 infusion for up to 6 months for central venous catheter management
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-07047 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |