Spots Global Cancer Trial Database for Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma

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Trial Identification

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

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

Study ID: NCT00471679

Conditions

Neuroblastoma

Interventions

ethanol

Study Description

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.

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.