A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2003-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Lymphocytic Leukemia Leukemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Vincristine

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No