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Pharmacokinetics of Dactinomycin in Young Patients With Cancer

NCT ID: NCT00900354

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

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unspecified childhood solid tumor, protocol specific

Interventions

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molecular genetic technique

Intervention Type GENETIC

mass spectrometry

Intervention Type OTHER

pharmacological study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Cancer and Leukaemia Group

OTHER

Sponsor Role lead

Principal Investigators

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Gareth Veal

Role: STUDY_CHAIR

University of Newcastle Upon-Tyne

Alan Boddy, PhD

Role:

University of Newcastle Upon-Tyne

Locations

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Our Lady's Hospital for Sick Children Crumlin

Dublin, , Ireland

Site Status RECRUITING

Birmingham Children's Hospital

Birmingham, England, United Kingdom

Site Status RECRUITING

Institute of Child Health at University of Bristol

Bristol, England, United Kingdom

Site Status RECRUITING

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status RECRUITING

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status RECRUITING

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, United Kingdom

Site Status RECRUITING

Middlesex Hospital

London, England, United Kingdom

Site Status RECRUITING

Great Ormond Street Hospital for Children

London, England, United Kingdom

Site Status RECRUITING

Royal Manchester Children's Hospital

Manchester, England, United Kingdom

Site Status RECRUITING

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, United Kingdom

Site Status RECRUITING

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

Newcastle upon Tyne, England, United Kingdom

Site Status RECRUITING

Queen's Medical Centre

Nottingham, England, United Kingdom

Site Status RECRUITING

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Site Status RECRUITING

Children's Hospital - Sheffield

Sheffield, England, United Kingdom

Site Status RECRUITING

Southampton General Hospital

Southampton, England, United Kingdom

Site Status RECRUITING

Royal Marsden - Surrey

Sutton, England, United Kingdom

Site Status RECRUITING

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, United Kingdom

Site Status RECRUITING

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, United Kingdom

Site Status RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Site Status RECRUITING

Royal Hospital for Sick Children

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Childrens Hospital for Wales

Cardiff, Wales, United Kingdom

Site Status RECRUITING

Countries

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Ireland United Kingdom

Facility Contacts

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Fin Breatnach, MD, FRCPE

Role: primary

Martin W. English, MD

Role: primary

Pamela Kearns, MD

Role: primary

Amos Burke, MD

Role: primary

Adam Glaser, MD

Role: primary

Mabrouk Madi, MD

Role: primary

Heather P. McDowell, MD

Role: primary

Ananth Shankar, MD

Role: primary

Gill Levitt, MD

Role: primary

Bernadette Brennan, MD

Role: primary

Juliet Hale, MD

Role: primary

Gareth Veal

Role: primary

Martin Hewitt, MD, BSc, FRCP, FRCPCH

Role: primary

Kate Wheeler, MD

Role: primary

Mary P. Gerrard, MBChB, FRCP, FRCPCH

Role: primary

Janice A. Kohler, MD, FRCP

Role: primary

Mary Taj, MD

Role: primary

Anthony McCarthy, MD

Role: primary

Veronica Neefjes

Role: primary

W. Hamish Wallace, MD

Role: primary

Milind D. Ronghe, MD

Role: primary

Heidi Traunecker, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 30167756 (View on PubMed)

Other Identifiers

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CDR0000531136

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT-2005-002996-34

Identifier Type: -

Identifier Source: secondary_id

EU-20643

Identifier Type: -

Identifier Source: secondary_id

CCLG-CTA-21275/0218/001-0001

Identifier Type: -

Identifier Source: secondary_id

CCLG-PK-2006-07

Identifier Type: -

Identifier Source: org_study_id