Know Cancer

or
forgot password

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


Phase 1
N/A
N/A
Not Enrolling
Both
Neuroblastoma

Thank you

Trial Information

Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mark L. Kayton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-047

NCT ID:

NCT00471679

Start Date:

April 2007

Completion Date:

February 2010

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021