A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Recruitment status was Recruiting
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer|
- 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.
|Study Start Date:||June 2004|
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.
|United States, Pennsylvania|
|Abramson Research Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Donna Sylvester, RN, BSN, BA, CCRC 215-590-3284|
|Principal Investigator: Jeffrey Skolnik, MD|