A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

This study has been completed.

First Received: November 3, 1999 Last Updated: March 3, 2008 History of Changes

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001689

Purpose

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.

Condition	Intervention	Phase
Acute Lymphocytic Leukemia Leukemia	Drug: Vincristine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Vincristine Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	90
Study Start Date:	January 1998
Estimated Study Completion Date:	November 2003

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001689

Locations

United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Publications:

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.

de 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.

Adamson PC, Poplack DG, Balis FM. Pharmacology and drug resistance in childhood lymphoblastic leukemia. Hematol Oncol Clin North Am. 1990 Oct;4(5):871-94. Review.

Study ID Numbers:	980053, 98-C-0053
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00001689 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Neurotoxicity
A.L.L.
Limited Sampling
Dose Individualization
Vinca Alkaloids

Study placed in the following topic categories:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Neurotoxicity Syndromes
Vinca Alkaloids
Vincristine
Antimitotic Agents

Leukemia
Lymphatic Diseases
Tubulin Modulators
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Mitosis Modulators
Vincristine

Antimitotic Agents
Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Tubulin Modulators
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 02, 2009