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

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00471679

Purpose

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
Neuroblastoma	Drug: ethanol	Phase I

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label
Official Title:	Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among Patients With High-Risk Neuroblastoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety and tolerability

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

Estimated Enrollment:	50
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471679

Locations

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)

Investigators

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000544497, MSKCC-07047
Study First Received:	May 8, 2007
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00471679 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Anti-Infective Agents, Local
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Central Nervous System Depressants
Neuroepithelioma

Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Ethanol
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Central Nervous System Depressants
Pharmacologic Actions
Neuroblastoma
Neuroectodermal Tumors

Anti-Infective Agents, Local
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasms, Neuroepithelial
Central Nervous System Agents
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial
Ethanol

ClinicalTrials.gov processed this record on May 07, 2009