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

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	January 1998
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Acute Lymphocytic Leukemia Leukemia
Intervention ^ICMJE	Drug: Vincristine
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date	November 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001689
Responsible Party
Study ID Numbers ^ICMJE	980053, 98-C-0053
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	November 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP