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A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia


Phase 1
N/A
N/A
Not Enrolling
Both
Acute Lymphocytic Leukemia, Leukemia

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Trial Information

A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

980053

NCT ID:

NCT00001689

Start Date:

January 1998

Completion Date:

November 2003

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Leukemia
  • Neurotoxicity
  • A.L.L.
  • Limited Sampling
  • Dose Individualization
  • Vinca Alkaloids
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892