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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471679

Enrollment

Registered

2007-05-10

Start date

2007-04-30

Completion date

2010-02-28

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

disseminated neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma

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.

Interventions

DRUGethanol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	2 years

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026