An observational study in Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Children's Cancer and Leukaemia Group. Status unknown at 22 sites in 2 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Children's Cancer and Leukaemia Group · Observational
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:
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.
Children's Cancer and Leukaemia Group is the lead sponsor of 46 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Children's Cancer and Leukaemia Group