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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471679
• Other study ID #: 07-047
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2007
• Last updated: March 4, 2013
• Start date: April 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• ethanol

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		2 years	Yes
Secondary	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	No