NCT00900354

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
2 countries

22 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

August 12, 2013

Status Verified

June 1, 2009

First QC Date

May 9, 2009

Last Update Submit

August 9, 2013

Conditions

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (22)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

RECRUITING

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

RECRUITING

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

RECRUITING

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

RECRUITING

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

RECRUITING

University of Newcastle-Upon-Tyne Northern Institute for Cancer Research

Newcastle upon Tyne, England, NE2 4HH, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

RECRUITING

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

RECRUITING

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

RECRUITING

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

RECRUITING

Related Publications (1)

  • Kim HY, Veal GJ, Zhou F, Boddy AV. The role of solute carrier (SLC) transporters in actinomycin D pharmacokinetics in paediatric cancer patients. Eur J Clin Pharmacol. 2018 Dec;74(12):1575-1584. doi: 10.1007/s00228-018-2544-z. Epub 2018 Aug 30.

MeSH Terms

Interventions

Genetic TestingMass Spectrometry

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesChemistry Techniques, Analytical

Study Officials

  • Gareth Veal

    University of Newcastle Upon-Tyne

    STUDY CHAIR
  • Alan Boddy, PhD

    University of Newcastle Upon-Tyne

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 1, 2006

Last Updated

August 12, 2013

Record last verified: 2009-06

Locations