Leukemia Clinical Trial
Official title:
The Pharmacokinetics and Pharmacodynamics of Vincristine in the Adolescent and Young Adult Population Compared to Younger Children
Verified date | June 2015 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The trial is to determine if a difference exists in the way that adolescents and young adults metabolize the chemotherapy agent vincristine compared to younger children.
Status | Unknown status |
Enrollment | 30 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 24 Years |
Eligibility |
Inclusion Criteria: - Patients ages 1-24 years of age with Acute Lymphoblastic Leukemia - Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in Induction phase of therapy - Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in first remission in Maintenance phase of therapy Treatment plan for induction therapy includes vincristine given at weekly intervals. - Treatment plan for Maintenance therapy includes vincristine given at monthly intervals. Exclusion Criteria: - Patients without a central line in induction phase of therapy |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vincristine (concentration of vincristine) | We will evaluate the concentration of vincristine in relations to the production of primary metabolite M1 over time. Vincristine is primary metabolized using CYP3A family of enzymes is responsible. | 4 weeks | |
Secondary | Calpain level | Serum calpain enzyme activity will be measured at three time points: 1) just prior to the first dose of vincristine to establish baseline levels; 2) 24 hours after the first dose of vincristine to measure acute effects of vincristine on enzyme activity; 3) after the 4th weekly vincristine (Induction) or after 4 weeks since last VCR dose (Maintenance) to assess chronic effects | 4 weeks | |
Secondary | Cytochrome P450 3A5 genotype | One whole blood sample will be collected for DNA extraction and genotyping from each subject enrolled in this study. | One time | |
Secondary | Development of Vincristine Induced Neuropathy | To screen for development of VRNT, we will employ two validated measures, the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 4.0)24 and the Pediatric-Modified Total Neuropathy Score. | 4 weeks |
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