Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00471679|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : March 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: ethanol||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among Patients With High-Risk Neuroblastoma|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: Ethanol-Lock Treatment
Ethanol instillation and removal will be carried out by one of the investigating physicians, a pediatric surgical nurse practitioner, or a dedicated research nurse. Syringes containing a 70% ethanol solution will be pre-filled in the PDH pharmacy and dispensed to the nurse caring for a particular patient. The volume of ethanol to be administered into each lumen of the central line will be specific to each patient's catheter and will be determined at enrollment.
- Safety and tolerability [ Time Frame: 2 years ]
- Efficacy, in terms of 6-month infection-free rate, cumulative incidence of infection, cumulative incidence of central line removal, and median time to infection [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471679
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Mark L. Kayton, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Michael P. LaQuaglia, MD||Memorial Sloan Kettering Cancer Center|