Trials / Completed
CompletedNCT00001689
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (planned)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vincristine |
Timeline
- Start date
- 1998-01-01
- Completion
- 2003-11-01
- First posted
- 1999-11-04
- Last updated
- 2008-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00001689. Inclusion in this directory is not an endorsement.