Pharmacokinetics of Ch14.18 in Younger Patients With High-Risk Neuroblastoma
NCT ID: NCT01418495
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2011-05-26
Brief Summary
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Detailed Description
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I. Describe the pharmacokinetics of ch14.18 (monoclonal antibody Ch14.18) in children with high-risk neuroblastoma.
II. Quantify the degree of inter-patient and intra-patient variability in the clearance of ch14.18, and correlate ch14.18 clearance with patient characteristics, the presence of human anti-chimeric antibody (HACA), tumor burden (assessed on scans), and plasma GD2 levels to identify sources of variability in the clearance.
III. Develop a pharmacokinetic model to describe the pharmacokinetic profile of ch14.18 and derive pharmacokinetic (PK) parameters.
SECONDARY OBJECTIVES:
I. Correlate plasma concentrations of ch14.18 with the severity of neuropathic pain, which is being quantified using an observational pain scale, and the total dose of morphine administered to control pain.
II. Develop a limited sampling strategy that will accurately quantify the area under the curve (AUC) of ch14.18.
III. Simulate alternative dosing strategies with the pharmacokinetic model in order to reduce variability and simplify drug administration.
OUTLINE:
Patients undergo blood sample collection at baseline and during and after course 1, 3, or 5 of treatment for pharmacokinetic analysis. Some patients undergo blood sample collection at baseline and during and after two treatment courses (1 and 3, 1 and 5, or 3 and 5).
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Ancillary-Correlative (pharmacokinetics of ch14.18)
Patients undergo blood sample collection at baseline and during and after course 1, 3, or 5 of treatment for pharmacokinetic analysis. Some patients undergo blood sample collection at baseline and during and after two treatment courses (1 and 3, 1 and 5, or 3 and 5).
Cytology Specimen Collection Procedure
Correlative studies
Pharmacological Study
Correlative studies
Interventions
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Cytology Specimen Collection Procedure
Correlative studies
Pharmacological Study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled on the COG protocol ANBL0032 or ANBL0931 and eligible to receive ch14.18 according to the criteria on these primary treatment protocols
* Parental informed consent and verbal assent of the subject when appropriate
Exclusion Criteria
* Anaphylactic reaction to ch14.18 on a prior treatment cycle
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Frank M Balis
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2011-02975
Identifier Type: REGISTRY
Identifier Source: secondary_id
CHP-1002
Identifier Type: -
Identifier Source: secondary_id
CDR0000701215
Identifier Type: -
Identifier Source: secondary_id
CHP1002
Identifier Type: OTHER
Identifier Source: secondary_id
9122
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02975
Identifier Type: -
Identifier Source: org_study_id
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