Neuroblastoma Clinical Trial
Official title:
Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among Patients With High-Risk Neuroblastoma
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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