Search / Trial NCT00001689

A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Trial Information

Current as of December 26, 2024

Completed

Keywords

Neurotoxicity A.L.L. Limited Sampling Dose Individualization Vinca Alkaloids

ClinConnect 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 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.

Gender

ALL

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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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