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Trial record 1 of 1 for:    ch14.18, study CHP1002
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Pharmacokinetics of Ch14.18 in Younger Patients With High-Risk Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01418495
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date August 16, 2011
First Posted Date August 17, 2011
Last Update Posted Date October 1, 2019
Actual Study Start Date May 26, 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 30, 2019)
  • PK parameters of monoclonal antibody ch14.18 in children with high?risk neuroblastoma during and after 4 daily 10?hour infusions [ Time Frame: Before and after infusion on days 3-5; before, after, 4-6 hours after, and 12-14 hours after infusion on day 6; on the morning of days 10, 14, 17, and 24; and before infusion on day 31 ]
    PK parameters include the peak concentration, trough concentration, AUC, clearance, volume of distribution, half-life, and mean residence time. PK parameters will be derived from the plasma concentration-time data. A one-compartment model fit to the concentration-time data will estimated the volume of distribution and the first order elimination rate constant, which will in turn be used to calculate clearance, half-life, AUC0-infinity, AUC0-last, and the mean residence time. An error function and the dependency for each fitted parameter will be reported.
  • Coefficient of variation of monoclonal antibody ch14.18 clearance [ Time Frame: Up to 58 days ]
    The coefficient of variation of Ch14.18 clearance is used to quantify the degree of inter-patient and intra-patient variability of monoclonal antibody ch14.18 pharmacokinetics. The relationship between patient characteristics, HACA, tumor burden, and plasma GD2 levels will be assessed graphically in an exploratory fashion with regression models.
Original Primary Outcome Measures
 (submitted: August 16, 2011)
  • PK parameters of Ch14.18 in children with high-risk neuroblastoma during and after 4 daily 10-hour infusions
  • Development of a PK model to describe the PK profile of Ch14.18 and derive PK parameters
Change History
Current Secondary Outcome Measures
 (submitted: September 30, 2019)
  • Severity of neuropathic pain, quantified using an observational pain scale based on the Face, Legs, Activity, Cry, Consolability scale (FLACC) and the total dose of morphine delivered [ Time Frame: Up to 58 days ]
    The pain measures will be correlated with plasma concentrations of monoclonal antibody ch14.18 simulated using the PK model and the monoclonal antibody ch14.18 AUC0-96 hours. The overall drug exposure during the infusion will be correlated with the total morphine dose administered over the 4 days of treatment.
  • AUC of Ch14.18 [ Time Frame: Up to 58 days ]
    A limited sampling strategy that will accurately quantify the AUC of monoclonal antibody ch14.18 will be developed.
  • Alternative dosing strategies [ Time Frame: Up to 58 days ]
    Alternative dosing strategies will be simulated with the pharmacokinetic model in order to reduce variability and simplify drug administration.
Original Secondary Outcome Measures
 (submitted: August 16, 2011)
  • Correlation between Ch14.18 plasma concentration and severity of neuropathic pain
  • Development of a limited-sampling strategy that accurately quantifies the AUC of Ch14.18
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Ch14.18 in Younger Patients With High-Risk Neuroblastoma
Official Title Pharmacokinetics of the Chimeric Anti-GD2 Antibody, ch14.18, in Children With High-Risk Neuroblastoma
Brief Summary This research trial is studying how Ch14.18 acts in the body of younger patients with high-risk neuroblastoma. Studying samples of blood from patients with cancer receiving Ch14.18 may help doctors learn more about how this drug is used by the body to develop better ways to give the drug to potentially improve its effectiveness and lessen its side effects.
Detailed Description

PRIMARY OBJECTIVES:

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).

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Patients with high-risk neuroblastoma enrolled on Children's Oncology Group (COG) ANBL0032 or ANBL0931
Condition
  • Localized Resectable Neuroblastoma
  • Localized Unresectable Neuroblastoma
  • Neurotoxicity Syndrome
  • Pain
  • Regional Neuroblastoma
  • Stage 4 Neuroblastoma
  • Stage 4S Neuroblastoma
Intervention
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Pharmacological Study
    Correlative studies
Study Groups/Cohorts 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).
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Pharmacological Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: August 16, 2011)
12
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of high-risk neuroblastoma
  • 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:

  • Prior testing demonstrating the presence of HACA
  • Anaphylactic reaction to ch14.18 on a prior treatment cycle
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01418495
Other Study ID Numbers NCI-2011-02975
NCI-2011-02975 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CHP-1002
CDR0000701215
CHP1002 ( Other Identifier: Children's Hospital of Philadelphia )
9122 ( Other Identifier: CTEP )
P30CA016520 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party National Cancer Institute (NCI)
Original Responsible Party Frank Milton Balis, Children's Hospital of Philadelphia
Current Study Sponsor National Cancer Institute (NCI)
Original Study Sponsor Children's Hospital of Philadelphia
Collaborators Not Provided
Investigators
Principal Investigator: Frank M Balis Children's Hospital of Philadelphia
PRS Account National Cancer Institute (NCI)
Verification Date September 2019