Spots Global Cancer Trial Database for A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
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Trial Identification
Brief Title: A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
Official Title: A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
Study ID: NCT00001689
Interventions
Study Description
Brief Summary: The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.
Detailed Description: The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL according to or on CCG protocols 1952/1962/1991. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Institute (NCI), Bethesda, Maryland, United States
Contact Details
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