Viewing Study NCT00001689



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001689
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
Status: COMPLETED
Status Verified Date: 2003-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 19521962 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 195219621991 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
98-C-0053 None None None