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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001689 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphocytic Leukemia Leukemia |
Drug: Vincristine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia |
| Estimated Enrollment: | 90 |
| Study Start Date: | January 1998 |
| Estimated Study Completion Date: | November 2003 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 980053, 98-C-0053 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001689 |
| Health Authority: | United States: Federal Government |
|
Neurotoxicity A.L.L. Limited Sampling Dose Individualization Vinca Alkaloids |
|
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Vinca Alkaloids |
Neurotoxicity Syndromes Neurotoxicity syndromes Vincristine Lymphoproliferative Disorders Lymphoma |
|
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |
