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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Neuroblastoma

Treatments: Drug: ethanol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00471679

P30CA008748 (U.S. NIH Grant/Contract)

MSKCC-07047

07-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Ethanol-Lock Treatment

Experimental group

Description:

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.

Treatment:

Drug: ethanol