Trial Information

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

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.