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

This study has been completed.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center Identifier:
First received: May 8, 2007
Last updated: March 4, 2013
Last verified: March 2013

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.

Condition Intervention Phase
Drug: ethanol
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ethanol-Lock Treatment
Ethanol instillation and removal will be carried out by one of the investigating physicians, a pediatric surgical nurse practitioner, or a dedicated research nurse. Syringes containing a 70% ethanol solution will be pre-filled in the PDH pharmacy and dispensed to the nurse caring for a particular patient. The volume of ethanol to be administered into each lumen of the central line will be specific to each patient's catheter and will be determined at enrollment.
Drug: ethanol

Detailed Description:



  • 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.


  • 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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00471679

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Principal Investigator: Mark L. Kayton, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Michael P. LaQuaglia, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center Identifier: NCT00471679     History of Changes
Other Study ID Numbers: 07-047, P30CA008748, MSKCC-07047
Study First Received: May 8, 2007
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents processed this record on April 15, 2014