A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 1998
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedMarch 4, 2008
November 1, 2003
November 3, 1999
March 3, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- All patients 1 year and less than 10 years of age.
- Patient must be diagnosed with acute lymphoblastic leukemia.
- All CCG patients must be enrolled on CCG 1952, 1962 or 1991 protocols, or be treated according to a CCG standard risk ALL protocol. NCI patients must be treated according to CCG 1952 for the treatment of standard risk ALL. Enrollment onto the current trial (CCG B9802) should if possible take place concurrently with enrollment onto 1952/1962/1991 or start of treatment according to a CCG standard risk ALL protocol.
- All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.
You may not qualify if:
- Previous underlying peripheral neuropathy.
- Previous underlying central nervous system dysfunction.
- Children with CNS toxicity attributable to other chemotherapeutic agents will not be followed with the Purdue pegboard test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute (NCI)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Crom WR, de Graaf SS, Synold T, Uges DR, Bloemhof H, Rivera G, Christensen ML, Mahmoud H, Evans WE. Pharmacokinetics of vincristine in children and adolescents with acute lymphocytic leukemia. J Pediatr. 1994 Oct;125(4):642-9. doi: 10.1016/s0022-3476(94)70027-3.
PMID: 7931891BACKGROUNDde Graaf SS, Bloemhof H, Vendrig DE, Uges DR. Vincristine disposition in children with acute lymphoblastic leukemia. Med Pediatr Oncol. 1995 Apr;24(4):235-40. doi: 10.1002/mpo.2950240405.
PMID: 7700168BACKGROUNDAdamson PC, Poplack DG, Balis FM. Pharmacology and drug resistance in childhood lymphoblastic leukemia. Hematol Oncol Clin North Am. 1990 Oct;4(5):871-94.
PMID: 2262483BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
January 1, 1998
Study Completion
November 1, 2003
Last Updated
March 4, 2008
Record last verified: 2003-11