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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00471679
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: ethanol Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Principal Investigator: Mark L. Kayton, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Michael P. LaQuaglia, MD Memorial Sloan Kettering Cancer Center
More Information

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00471679     History of Changes
Other Study ID Numbers: 07-047
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

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
Central Nervous System Depressants
Physiological Effects of Drugs