A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

NCT00001689•National Cancer Institute (NCI)

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

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (1)

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Key Dates

Start Date

January 1, 1998

Completion Date

November 1, 2003

Last Updated

March 4, 2008

Enrollment

Estimated participants

Conditions

Acute Lymphocytic LeukemiaLeukemia

Interventions

Vincristine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

Inclusion Criteria

Exclusion Criteria

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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