Pharmacokinetics of Dactinomycin in Young Patients With Cancer

August 9, 2013 updated by: Children's Cancer and Leukaemia Group

Pharmacokinetics of Actinomycin D in Children With Cancer

RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving dactinomycin may help doctors learn how dactinomycin works in the body and how patients will respond to treatment.

PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young patients with cancer.

Study Overview

Detailed Description

OBJECTIVES:

  • Determine the pharmacokinetics (PKs) of dactinomycin in pediatric patients with cancer.
  • Determine the degree of interpatient variation in the PKs of this drug.
  • Determine the influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs in these patients.
  • Correlate drug PKs with clinical response and toxicity observed in these patients, focusing particularly on the incidence of severe liver toxicity or veno-occlusive disease.
  • Correlate pharmacogenetic variability with clinical and PK data.

OUTLINE: This is a multicenter study.

Patients undergo blood collection for pharmacokinetic sampling of dactinomycin at baseline (prior to the initiation of dactinomycin) and periodically during course 1 of chemotherapy. An additional blood sample is obtained before or after treatment for the collection of peripheral blood lymphocytes. DNA from these cells is isolated and investigated for genetic variation in genes relevant to the pharmacology of dactinomycin. Plasma concentrations of dactinomycin are determined by liquid chromatography mass spectrometry analysis.

Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dublin, Ireland, 12
        • Recruiting
        • Our Lady's Hospital for Sick Children Crumlin
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Children's Hospital
      • Bristol, England, United Kingdom, BS2 8AE
        • Recruiting
        • Institute of Child Health at University of Bristol
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
        • Contact:
          • Mabrouk Madi, MD
          • Phone Number: 44-116-258-5959
      • Liverpool, England, United Kingdom, L12 2AP
        • Recruiting
        • Royal Liverpool Children's Hospital, Alder Hey
      • London, England, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
        • Contact:
          • Gill Levitt, MD
          • Phone Number: 44-20-7405-9200 ext. 0073
      • London, England, United Kingdom, W1T 3AA
        • Recruiting
        • Middlesex Hospital
      • Manchester, England, United Kingdom, M27 4HA
        • Recruiting
        • Royal Manchester Children's Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
        • Recruiting
        • Sir James Spence Institute of Child Health at Royal Victoria Infirmary
      • Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH
        • Recruiting
        • University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
      • Nottingham, England, United Kingdom, NG7 2UH
        • Recruiting
        • Queen's Medical Centre
      • Oxford, England, United Kingdom, 0X3 9DU
        • Recruiting
        • Oxford Radcliffe Hospital
      • Sheffield, England, United Kingdom, S10 2TH
        • Recruiting
        • Children's Hospital - Sheffield
      • Southampton, England, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BE
        • Recruiting
        • Royal Belfast Hospital for Sick Children
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZG
        • Recruiting
        • Royal Aberdeen Children's Hospital
      • Edinburgh, Scotland, United Kingdom, EH9 1LF
        • Recruiting
        • Royal Hospital for Sick Children
      • Glasgow, Scotland, United Kingdom, G3 8SJ
        • Recruiting
        • Royal Hospital for Sick Children
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Recruiting
        • Childrens Hospital for Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Currently being treated with dactinomycin on a clinical trial at a United Kingdom Children's Cancer Study Group center

PATIENT CHARACTERISTICS:

  • Single- or double-lumen central venous catheter or portacath in place

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics (PKs) of dactinomycin
Degree of interpatient variation of drug PKs
Influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs
Correlation of drug PKs with clinical response and toxicity, particularly the incidence of severe liver toxicity or veno-occlusive disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Gareth Veal, University of Newcastle Upon-Tyne
  • Alan Boddy, PhD, University of Newcastle Upon-Tyne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • CCLG-PK-2006-07
  • CDR0000531136 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT-2005-002996-34
  • EU-20643
  • CCLG-CTA-21275/0218/001-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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