Unspecified Childhood Solid Tumor, Protocol SpecificNCT00900354
Pharmacokinetics of Dactinomycin in Young Patients With Cancer
An observational study of Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Cancer and Leukaemia Group at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- molecular genetic technique, mass spectrometry and pharmacological study
- How many people
- 50 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jun 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United Kingdom21 sites, 21 recruiting
- Recruiting
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Veronica Neefjes, 44-1224-550-217
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Anthony McCarthy, MD, 44-289-063-3631, anthonymcarthy@royalhospital.n.i.nhs.uk
- Recruiting
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Martin W. English, MD, 44-121-333-8412, martin.english@bch.nhs.uk
- Recruiting
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE
Pamela Kearns, MD, 44-117-342-8260
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Amos Burke, MD, 44-1223-348-151
- Recruiting
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Heidi Traunecker, MD, PhD, 44-29-2074-2285, heidi.traunecker@cardiffandvale.wales.nhs.uk
- Recruiting
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
W. Hamish Wallace, MD, 44-131-536-0426
- Recruiting
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Milind D. Ronghe, MD, 44-141-201-9309
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Adam Glaser, MD, 44-113-206-4984, adam.glaser@leedsth.nhs.uk
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Mabrouk Madi, MD, 44-116-258-5959
- Recruiting
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Heather P. McDowell, MD, 44-151-293-3679
- Recruiting
Middlesex Hospital
London, England, W1T 3AA
Ananth Shankar, MD, 44-20-7380-9300 ext. 9950
- Recruiting
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Gill Levitt, MD, 44-20-7405-9200 ext. 0073
- Recruiting
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Bernadette Brennan, MD, 44-161-922-2227, bernadette.brennan@cmmc.nhs.uk
- Recruiting
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Juliet Hale, MD, 44-191-282-4101, j.p.hale@ncl.ac.uk
- Recruiting
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, NE2 4HH
Gareth Veal, 44-191-246-4332
- Recruiting
Queen's Medical Centre
Nottingham, England, NG7 2UH
Martin Hewitt, MD, BSc, FRCP, FRCPCH, 44-115-924-9924 ext. 43394, martin.hewitt@nuh.nhs.uk
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Kate Wheeler, MD, 44-186-522-1066
- Recruiting
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Mary P. Gerrard, MBChB, FRCP, FRCPCH, 44-114-271-7366, mary.gerrard@sch.nhs.uk
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Janice A. Kohler, MD, FRCP, 44-23-8079-6942
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Mary Taj, MD, 44-20-8642-6011 ext. 1307
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12
Fin Breatnach, MD, FRCPE, 353-1-409-6659, fin.breatnach@olhsc.ie
About this study
Official title: 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.
Read the 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.
- Being tested
- molecular genetic technique, mass spectrometry, pharmacological study
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular genetic techniqueGenetic
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Gareth Veal, Study chair, University of Newcastle Upon-TyneAlan Boddy, PhD, University of Newcastle Upon-Tyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900354
- Sponsor's protocol ID
- CCLG-PK-2006-07
- Other IDs
- CDR0000531136, EUDRACT-2005-002996-34, EU-20643, CCLG-CTA-21275/0218/001-0001
- Status last verified
- Jun 2009
- First submitted
- 9 May 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Publications
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.
PubMed 30167756
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Actinomycin D in Children With Cancer
- ClinicalTrials.gov ID
- NCT00900354
- Acronym / sponsor ID
- CCLG-PK-2006-07
- Keywords
- unspecified childhood solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Jun 2006
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular genetic technique | Genetic | – |
| mass spectrometry | Other | – |
| pharmacological study | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Derived from this study: PubMed 30167756Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Veal study chair
University of Newcastle Upon-Tyne
Alan Boddy, PhD
University of Newcastle Upon-Tyne
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Cancer and Leukaemia Group at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PKs) of dactinomycin. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.