A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia - Tabular View

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A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

This study has been completed.

Study NCT00001689. Last updated on March 3, 2008. Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title ^†	A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
Official Title ^†	A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
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.
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.
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Acute Lymphocytic Leukemia Leukemia
Intervention ^†	Drug: Vincristine
MEDLINE PMIDs	7931891, 7700168, 2262483
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	90
Start Date ^†	January 1998
Completion Date	November 2003
Eligibility 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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00001689
Organization ID	980053
Secondary IDs ^††	98-C-0053
Study Sponsor ^†	National Cancer Institute (NCI)
Collaborators ^††
Investigators ^†
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	November 2003
First Received Date ^†	November 3, 1999
Last Updated Date	March 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.