Pharmacokinetics of Ch14.18 in Younger Patients With High-Risk Neuroblastoma

NCT01418495 | Completed

• 6 other identifiers: NCI-2011-02975CHP-1002CDR0000701215CHP10029122P30CA016520
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Neurotoxicity Syndrome; Pain; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma

Outcome Measures

Primary Outcomes (2)

• PK parameters of monoclonal antibody ch14.18 in children with high?risk neuroblastoma during and after 4 daily 10?hour infusions

  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.

  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

• Coefficient of variation of monoclonal antibody ch14.18 clearance

  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.

  Up to 58 days

Secondary Outcomes (3)

• 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

  Up to 58 days

• AUC of Ch14.18

  Up to 58 days

• Alternative dosing strategies

  Up to 58 days

Study Arms (1)

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).

Other: Cytology Specimen Collection Procedure; Other: Pharmacological Study

Interventions

Cytology Specimen Collection Procedure OTHER

Correlative studies

Also known as: Cytologic Sampling

Ancillary-Correlative (pharmacokinetics of ch14.18)

Pharmacological Study OTHER

Correlative studies

Ancillary-Correlative (pharmacokinetics of ch14.18)

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high-risk neuroblastoma enrolled on Children's Oncology Group (COG) ANBL0032 or ANBL0931

You may qualify if:

• 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

You may not qualify if:

• Prior testing demonstrating the presence of HACA
• Anaphylactic reaction to ch14.18 on a prior treatment cycle

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Neurotoxicity Syndromes; Pain; Neuroblastoma

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Frank M Balis

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: May 26, 2011
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

US (1)