Pharmacokinetics of Dactinomycin in Young Patients With Cancer
|ClinicalTrials.gov Identifier: NCT00900354|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 12, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment|
|Unspecified Childhood Solid Tumor, Protocol Specific||Genetic: molecular genetic technique Other: mass spectrometry Other: pharmacological study|
- 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|
|Estimated Enrollment :||50 participants|
|Official Title:||Pharmacokinetics of Actinomycin D in Children With Cancer|
|Study Start Date :||June 2006|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900354
|Our Lady's Hospital for Sick Children Crumlin||Recruiting|
|Dublin, Ireland, 12|
|Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 email@example.com|
|Birmingham Children's Hospital||Recruiting|
|Birmingham, England, United Kingdom, B4 6NH|
|Contact: Martin W. English, MD 44-121-333-8412 firstname.lastname@example.org|
|Institute of Child Health at University of Bristol||Recruiting|
|Bristol, England, United Kingdom, BS2 8AE|
|Contact: Pamela Kearns, MD 44-117-342-8260|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Contact: Amos Burke, MD 44-1223-348-151|
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Adam Glaser, MD 44-113-206-4984 email@example.com|
|Leicester Royal Infirmary||Recruiting|
|Leicester, England, United Kingdom, LE1 5WW|
|Contact: Mabrouk Madi, MD 44-116-258-5959|
|Royal Liverpool Children's Hospital, Alder Hey||Recruiting|
|Liverpool, England, United Kingdom, L12 2AP|
|Contact: Heather P. McDowell, MD 44-151-293-3679|
|London, England, United Kingdom, W1T 3AA|
|Contact: Ananth Shankar, MD 44-20-7380-9300 ext. 9950|
|Great Ormond Street Hospital for Children||Recruiting|
|London, England, United Kingdom, WC1N 3JH|
|Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073|
|Royal Manchester Children's Hospital||Recruiting|
|Manchester, England, United Kingdom, M27 4HA|
|Contact: Bernadette Brennan, MD 44-161-922-2227 firstname.lastname@example.org|
|Sir James Spence Institute of Child Health at Royal Victoria Infirmary||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Contact: Juliet Hale, MD 44-191-282-4101 email@example.com|
|University of Newcastle-Upon-Tyne Northern Institute for Cancer Research||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH|
|Contact: Gareth Veal 44-191-246-4332|
|Queen's Medical Centre||Recruiting|
|Nottingham, England, United Kingdom, NG7 2UH|
|Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 43394 firstname.lastname@example.org|
|Oxford Radcliffe Hospital||Recruiting|
|Oxford, England, United Kingdom, 0X3 9DU|
|Contact: Kate Wheeler, MD 44-186-522-1066|
|Children's Hospital - Sheffield||Recruiting|
|Sheffield, England, United Kingdom, S10 2TH|
|Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 email@example.com|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Mary Taj, MD 44-20-8642-6011 ext. 1307|
|Royal Belfast Hospital for Sick Children||Recruiting|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Contact: Anthony McCarthy, MD 44-289-063-3631 firstname.lastname@example.org|
|Royal Aberdeen Children's Hospital||Recruiting|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Contact: Veronica Neefjes 44-1224-550-217|
|Royal Hospital for Sick Children||Recruiting|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Contact: W. Hamish Wallace, MD 44-131-536-0426|
|Royal Hospital for Sick Children||Recruiting|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Contact: Milind D. Ronghe, MD 44-141-201-9309|
|Childrens Hospital for Wales||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 email@example.com|
|Study Chair:||Gareth Veal||University of Newcastle Upon-Tyne|
|OverallOfficial:||Alan Boddy, PhD||University of Newcastle Upon-Tyne|