Pharmacokinetics of Dactinomycin in Young Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900354
First received: May 9, 2009
Last updated: August 9, 2013
Last verified: June 2009
  Purpose

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 Intervention
Unspecified Childhood Solid Tumor, Protocol Specific
Genetic: molecular genetic technique
Other: mass spectrometry
Other: pharmacological study

Study Type: Observational
Official Title: Pharmacokinetics of Actinomycin D in Children With Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pharmacokinetics (PKs) of dactinomycin [ Designated as safety issue: No ]
  • Degree of interpatient variation of drug PKs [ Designated as safety issue: No ]
  • Influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs [ Designated as safety issue: No ]
  • Correlation of drug PKs with clinical response and toxicity, particularly the incidence of severe liver toxicity or veno-occlusive disease [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900354

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Fin Breatnach, MD, FRCPE    353-1-409-6659    fin.breatnach@olhsc.ie   
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B4 6NH
Contact: Martin W. English, MD    44-121-333-8412    martin.english@bch.nhs.uk   
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Pamela Kearns, MD    44-117-342-8260      
Addenbrooke's Hospital Recruiting
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    adam.glaser@leedsth.nhs.uk   
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      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Gill Levitt, MD    44-20-7405-9200 ext. 0073      
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD    44-20-7380-9300 ext. 9950      
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227    bernadette.brennan@cmmc.nhs.uk   
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    j.p.hale@ncl.ac.uk   
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    martin.hewitt@nuh.nhs.uk   
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    mary.gerrard@sch.nhs.uk   
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    anthonymcarthy@royalhospital.n.i.nhs.uk   
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    heidi.traunecker@cardiffandvale.wales.nhs.uk   
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Gareth Veal University of Newcastle Upon-Tyne
Investigator: Alan Boddy, PhD University of Newcastle Upon-Tyne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00900354     History of Changes
Other Study ID Numbers: CCLG-PK-2006-07, CDR0000531136, EUDRACT-2005-002996-34, EU-20643, CCLG-CTA-21275/0218/001-0001
Study First Received: May 9, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 16, 2014