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.

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