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

United States Department of Health and Human Services (HHS)

Status and phase

Unknown

Phase 4

Conditions

Cancer

Treatments

Drug: Actinomycin-D

Drug: Vincristine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00491946

PPRU 10762

Details and patient eligibility

About

To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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