Clinical trial · Interventional
Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Pharmacokinetics of Daunomycin in Children
NCT00673257CI-TRIAL-00044651completedN/AResults postedClinicalTrials.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 laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dual x-ray absorptimetry | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pharmacokinetics of Daunorubicin chemotherapy patients
- description
- Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
- interventionNames
- Other: pharmacological study
- Procedure: dual x-ray absorptimetry
Primary outcomes (2)
- measure
- Population Estimates for Daunorubicin Hydrochloride Clearance
- timeFrame
- Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of any malignancy * Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride administered as an infusion of any duration for \< 24 hours on either a 1- or a 2-day schedule, including bolus and all short infusion schedules PATIENT CHARACTERISTICS: * Not pregnant or nursing * No significant uncontrolled systemic illness * Large implanted prostheses allowed (should not undergo dual energy x-ray absorptiometry scan) PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.