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A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

Phase 4
18 Years
Open (Enrolling)

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Trial Information

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Study ID:

PPRU 10762



Start Date:

June 2004

Completion Date:

Related Keywords:

  • Cancer
  • Cancer
  • Actinomycin
  • Vincristine



Abramson Research Center Philadelphia, Pennsylvania  19104