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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674193
• Other study ID #: ADVL06B1
• Secondary ID: NCI-2009-00362CO
• Status: Completed
• Phase: N/A
• First received: May 6, 2008
• Last updated: May 15, 2017
• Start date: February 2008

Study information

• Verified date: May 2017
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

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

Intervention

Other:
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
Australia	Princess Margaret Hospital for Children	Perth	Western Australia
Canada	Hospital Sainte-Justine	Montreal	Quebec
United States	C S Mott Children's Hospital	Ann Arbor	Michigan
United States	Mission Hospitals Inc	Asheville	North Carolina
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Childrens Memorial Hospital	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Rainbow Babies and Childrens Hospital	Cleveland	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Nemours Children's Clinic - Jacksonville	Jacksonville	Florida
United States	East Tennessee Childrens Hospital	Knoxville	Tennessee
United States	Miller Children's Hospital	Long Beach	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Midwest Children's Cancer Center	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Advocate Hope Children's Hospital	Oak Lawn	Illinois
United States	Childrens Hospital of Orange County	Orange	California
United States	Nemours Childrens Clinic - Orlando	Orlando	Florida
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Methodist Children's Hospital of South Texas	San Antonio	Texas
United States	Rady Children's Hospital - San Diego	San Diego	California
United States	University of California San Francisco Medical Center-Parnassus	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Saint Joseph Children's Hospital of Tampa	Tampa	Florida
United States	Children's National Medical Center	Washington, D.C.	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population PK parameters for dactinomycin and VCR		Not Provided
Primary	Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition		Not Provided
Secondary	Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)		Not Provided
Secondary	Pharmacogenetic profiles of patients receiving dactinomycin and VCR		Not Provided
Secondary	Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children		Not Provided
Secondary	Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes		Not Provided
Secondary	Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes		Not Provided