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A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children with Leukemia



A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children with Leukemia

For Condition: Acute Lymphocytic Leukemia,Leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 90

Location and Contact Information:

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


Additional Information:
Study ID Numbers:  980053;  98-C-0053
Study Start Date: January 22, 1998
Record last reviewed: November 26, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001689

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