Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

Official title: A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.

II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.

III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.

IV. To identify demographic or physiological factors that are determinants of VCR disposition.

SECONDARY OBJECTIVES:

I. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.

II. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.

OUTLINE: This is a multicenter study.

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.

After the final pharmacokinetic sample is collected, patients are followed for up to 6 months. ;

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia
• Childhood Rhabdomyosarcoma
• Childhood Soft Tissue Sarcoma
• Ewing Sarcoma
• Ewing Sarcoma of Bone
• Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
• Kidney Neoplasms
• Leukemia, Lymphoid
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroectodermal Tumors, Primitive, Peripheral
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing
• Unspecified Childhood Solid Tumor, Protocol Specific
• Wilms Tumor
• Wilms Tumor and Other Childhood Kidney Tumors

• NCT number: NCT00674193
• Study type: Observational
• Source: Children's Oncology Group
• Status: Completed
• Phase: N/A
• Start date: February 2008