Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among Patients With High-Risk Neuroblastoma

Conditions
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Neuroblastoma

Intervention / Treatment
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* Drug: ethanol


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels High-risk disease Currently enrolled on clinical trial MSKCC-03077 Expected duration of therapy ≥ 6 months Surgically-implanted central venous catheter with documented patency Must be able to establish patency of central venous catheter lumen No history of culture-positive central venous catheter infection in catheter to be treated PATIENT CHARACTERISTICS: Bilirubin < 1.5 times upper limit of normal (ULN) AST and ALT < 2.5 times ULN Alkaline phosphatase < 2.5 times ULN No history of hypersensitivity to ethanol No history or documented active seizure disorder No documented acute liver failure PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent total parenteral nutrition or other infusion requiring use of the central line at night No concurrent levetiracetam or other anticonvulsants
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethanol-Lock Treatment<br>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. | Drug: ethanol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, in terms of 6-month infection-free rate, cumulative incidence of infection, cumulative incidence of central line removal, and median time to infection |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disseminated neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma