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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-07047 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ethanol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
No history of culture-positive central venous catheter infection in catheter to be treated
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark L. Kayton, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Michael P. LaQuaglia, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |