A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for
young children with cancer, with resultant increased risk of morbidity, mortality and
inferior outcome. Of the anti-cancer agents used frequently in infants and young children,
the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used
for the treatment of several childhood cancers since the 1960s. Despite its longstanding and
widespread use in pediatric oncology, there is virtually no pharmacokinetic information from
which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an
integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists
will continue to administer the durg despite the gap in knowledge.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy.
United States: Federal Government
PPRU 10762
NCT00491946
June 2004
Name | Location |
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Abramson Research Center | Philadelphia, Pennsylvania 19104 |