A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Actinomycin-D (Drug); Vincristine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Summary
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in
children with cancer.
Clinical Details
Official title: A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: 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.
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.
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Abramson Research Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Donna Sylvester, RN, BSN, BA, CCRC, Phone: 215-590-3284
Jeffrey Skolnik, MD, Principal Investigator
Additional Information
Pediatric Pharmacology Research Unit Website
Starting date: June 2004
Last updated: June 25, 2007
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