Clinical trial · Observational
Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
NCT00897871CI-TRIAL-00011720unknownClinicalTrials.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)
RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how patients will respond to treatment. PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs work in very young patients with cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Pharmacokinetic parameters
- measure
- Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites
- measure
- Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival
- measure
- Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 2 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of childhood cancer * Receiving carboplatin, cyclophosphamide, or etoposide as standard treatment as part of a clinical study at a Children's Cancer and Leukemia Group (CCLG) center PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Single or double lumen central venous catheter in place * No concurrent anticonvulsants, azole antifungal agents, or chronic steroid treatment
References
Publications (0)
Data not yet available
No reference posted for this study.