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

May 9, 2009
August 9, 2013
June 2006
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  • 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 ]
Same as current
Complete list of historical versions of study NCT00900354 on ClinicalTrials.gov Archive Site
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Pharmacokinetics of Dactinomycin in Young Patients With Cancer
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.

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.

Observational
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Unspecified Childhood Solid Tumor, Protocol Specific
  • Genetic: molecular genetic technique
  • Other: mass spectrometry
  • Other: pharmacological study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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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
Both
up to 21 Years
No
United Kingdom,   Ireland
 
NCT00900354
CCLG-PK-2006-07, CDR0000531136, EUDRACT-2005-002996-34, EU-20643, CCLG-CTA-21275/0218/001-0001
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Children's Cancer and Leukaemia Group
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Study Chair: Gareth Veal University of Newcastle Upon-Tyne
Investigator: Alan Boddy, PhD University of Newcastle Upon-Tyne
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP