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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00471679
First received: May 8, 2007
Last updated: March 4, 2013
Last verified: March 2013
History of Changes

May 8, 2007
March 4, 2013
April 2007
February 2010   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Safety and tolerability
Complete list of historical versions of study NCT00471679 on ClinicalTrials.gov Archive Site
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 ]
Efficacy in terms of 6-month infection-free rate, cumulative incidence of infection, cumulative incidence of central line removal, and median time to infection
Not Provided
Not Provided
 
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

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Neuroblastoma
Drug: ethanol
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.
Intervention: Drug: ethanol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00471679
07-047, P30CA008748, MSKCC-07047
Not Provided
Memorial Sloan-Kettering Cancer Center
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
Memorial Sloan-Kettering Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP