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

Memorial Sloan Kettering Cancer Center12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neuroblastoma

Interventions

ethanolDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Safety and tolerability

Time frame: 2 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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