NCT00471679

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

May 8, 2007

Last Update Submit

March 4, 2013

Conditions

Neuroblastoma

Keywords

disseminated neuroblastomalocalized unresectable neuroblastomarecurrent neuroblastomaregional neuroblastomastage 4S neuroblastoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    2 years

Secondary Outcomes (1)

  • 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

Study Arms (1)

Ethanol-Lock Treatment

EXPERIMENTAL

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.

Drug: ethanol

Interventions

ethanolDRUG
Ethanol-Lock Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Mark L. Kayton, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Michael P. LaQuaglia, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

April 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(1)