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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00471679 |
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.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: ethanol |
Phase I |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label |
Official Title: | Phase I Study of an Ethanol-Lock Strategy to Prevent Central Venous Catheter Infections Among Patients With High-Risk Neuroblastoma |
Estimated Enrollment: | 50 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels
Currently enrolled on clinical trial MSKCC-03077
Surgically-implanted central venous catheter with documented patency
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Mark L. Kayton, MD 212-639-7966 |
Principal Investigator: | Mark L. Kayton, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Michael P. LaQuaglia, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000544497, MSKCC-07047 |
Study First Received: | May 8, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00471679 |
Health Authority: | Unspecified |
disseminated neuroblastoma localized unresectable neuroblastoma recurrent neuroblastoma regional neuroblastoma stage 4S neuroblastoma |
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral |
Recurrence Neuroblastoma Ethanol Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Anti-Infective Agents, Local Neoplasms Neoplasms by Histologic Type Therapeutic Uses Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Central Nervous System Depressants Neoplasms, Neuroepithelial Central Nervous System Agents Pharmacologic Actions |