Status:
COMPLETED
Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE1
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-loc...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00471679
Start Date
April 1 2007
End Date
February 1 2010
Last Update
March 5 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021