Cancer
Conditions
Keywords
Cancer, Actinomycin, Vincristine
Brief summary
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.
Detailed description
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.
Interventions
DRUGActinomycin-D
DRUGVincristine
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 6 months - 18 years * Due to receive actinomycin-D as a component of cancer treatment * Central venous catheter (e.g. Port-a Cath, Broviac) * Informed consent of parent or legal guardian and patient assent when appropriate
Exclusion criteria
* Serious illness other than the primary diagnosis of cancer * Weight \< 5 kilograms * Previous participation in CHP-810
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed