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

Phase 4

• Conditions: Cancer

• Registration Number: NCT00491946
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Timeline

• Study Start: 2004-06
• Status Verified: 2007-06
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-25
• Last Update Submitted: 2007-06-25
• Study First Posted: 2007-06-26
• Last Update Posted: 2007-06-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Abramson Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States