Clinical trial · Observational
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer
A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
NCT00674193CI-TRIAL-00027632completedClinicalTrials.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 evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Childhood Rhabdomyosarcoma | Childhood Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Soft Tissue Sarcoma | Childhood Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ewing Sarcoma of Bone | Bone Ewing Sarcoma | ALIAS | 0.90 |
| Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | ONTOLOGY_EXACT | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
| Wilms Tumor and Other Childhood Kidney Tumors | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (pharmacological study)
- description
- Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.
- interventionNames
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Population PK parameters for dactinomycin and VCR
- timeFrame
- Not Provided
- measure
- Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition
- timeFrame
- Not Provided
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cancer, including, but not limited to, any of the following: * Acute lymphoblastic leukemia * Ewing sarcoma * Rhabdomyosarcoma * Soft tissue sarcoma * Wilms tumor * Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial * Able to comply with study requirements * Other concurrent chemotherapeutic agents allowed
References
Publications (0)
Data not yet available
No reference posted for this study.