Evaluating Dactinomycin and Vincristine in Young Patients With Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

November 19, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Population PK parameters for dactinomycin and VCR
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00674193 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)
Pharmacogenetic profiles of patients receiving dactinomycin and VCR
Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children
Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes
Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

Official Title ^ICMJE

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

Brief Summary

RATIONALE: 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.

PURPOSE: This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer.

Detailed Description

OBJECTIVES:

Primary

To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.
To identify demographic or physiological factors that are determinants of dactinomycin disposition.
To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.
To identify demographic or physiological factors that are determinants of VCR disposition.

Secondary

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Kidney Cancer
Leukemia
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^ICMJE

Biological: dactinomycin
Drug: vincristine sulfate
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: liquid chromatography
Other: mass spectrometry
Other: pharmacological study

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

260

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Able to comply with study requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Other concurrent chemotherapeutic agents allowed

Gender

Both

Ages

up to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Australia, Canada

Administrative Information

NCT ID ^ICMJE

NCT00674193

Responsible Party

Study ID Numbers ^ICMJE

CDR0000559243, COG-ADVL06B1

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Jeffrey M. Skolnik, MD

Children's Hospital of Philadelphia

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP