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

Tracking Information
First Received Date ^ICMJE	June 22, 2007
Last Updated Date	June 25, 2007
Start Date ^ICMJE	June 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2007)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00491946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Official Title ^ICMJE	A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
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 Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: Actinomycin-D Drug: Vincristine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	24
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00491946
Responsible Party
Study ID Numbers ^ICMJE	PPRU 10762
Study Sponsor ^ICMJE	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date	June 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP