Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

Completed

• Conditions: Ewing Sarcoma of Bone; Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET); Unspecified Childhood Solid Tumor, Protocol Specific; Childhood Acute Lymphoblastic Leukemia; Childhood Soft Tissue Sarcoma; Childhood Rhabdomyosarcoma; Ewing Sarcoma; Wilms Tumor and Other Childhood Kidney Tumors

• Registration Number: NCT00674193
• Lead Sponsor: Children's Oncology Group

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2016-06-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Population PK parameters for dactinomycin and VCR	Not Provided
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition	Not Provided

Secondary Outcome Measures

Name	Time	Method
Pharmacogenetic profiles of patients receiving dactinomycin and VCR	Not Provided
Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children	Not Provided
Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes	Not Provided
Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)	Not Provided
Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes	Not Provided

Trial Locations

Locations (38)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Miller Children's Hospital; 🇺🇸 Long Beach, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Childrens Hospital of Orange County; 🇺🇸 Orange, California, 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

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Children's National Medical Center; 🇺🇸 Washington, D.C., District of Columbia, United States

Nemours Children's Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Nemours Childrens Clinic - Orlando; 🇺🇸 Orlando, Florida, United States

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