Clinical trial · Observational
Pharmacokinetics of Ch14.18 in Younger Patients With High-Risk Neuroblastoma
Pharmacokinetics of the Chimeric Anti-GD2 Antibody, ch14.18, in Children With High-Risk Neuroblastoma
NCT01418495CI-TRIAL-00040927completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Resectable Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Localized Unresectable Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Neurotoxicity Syndrome | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Regional Neuroblastoma | Regional Neuroblastoma | ONTOLOGY_EXACT | 0.98 |
| Stage 4 Neuroblastoma | — | UNRESOLVED | — |
| Stage 4S Neuroblastoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (pharmacokinetics of ch14.18)
- description
- 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).
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Pharmacological Study
Primary outcomes (2)
- measure
- PK parameters of monoclonal antibody ch14.18 in children with high?risk neuroblastoma during and after 4 daily 10?hour infusions
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 15 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.