Biospecimen Collection: Undergo collection of blood samples
Vincristine: Given IV per standard of care
Study summary
This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.
Eligibility
Sex
ALL
Min age
—
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients must be =\< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups:
* 0 to 6 months
* 6 months and 1 day to 12 months
* 12 months and 1 day to 36 months
* 36 months and 1 day to 12 years with a BSA ≥ 0.6 m\^2
* Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m\^2 dose level
* Any disease status
* Patients must have a Lansky performance status of 50 or higher
* Patients must be receiving a treatment regimen that includes 1.5 mg/m\^2 vinCRIStine (maximum dose 2 mg)
* Patients with a BSA \< 0.6 m\^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine
* Note: Patients can be studied after any dose of vinCRIStine
* Patients who are NOT enrolled on a COG clinical trial and who have a BSA \< 0.6 m\^2 and who are being dosed according to another infant dosing method (e.g., the 30-Rule) can receive a dose of vinCRIStine from the infant dosing table for the pharmacokinetic study. These patients will NOT be part of the Dose Modification Assessment
* Patients with a seizure disorder may be enrolled if on allowable anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days
* Nervous system toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\]) version (v)5 resulting from prior therapy must be grade =\< 2
* Central venous access device in place (e.g., percutaneous indwelling central catheter \[PICC\], port, Broviac) or scheduled to be placed prior to the dose of vinCRIStine and that can be used for pharmacokinetic (PK) sampling
* VinCRIStine may be given as an outpatient, as long as all sample time points can be collected, which will require return for hour 24 sampling
Exclusion Criteria:
* Azoles antifungals and macrolide antibiotics: Patients who are currently receiving an azole or macrolide (e.g., fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, ketoconazole, eryromycin, clarithromycin, azithromycin, roxithromycin, or telithromycin) are not eligible
* CYP3A4/5 inducers/inhibitors: Patients receiving any medications or substances that are considered moderate or strong inhibitors or inducers of CYP3A4/5 are not eligible. Moderate or strong inducers or inhibitors of CYP3A4/5 should be avoided from 14 days prior to enrollment to the end of the study.
* Note the following are allowed:
* Dexamethasone for CNS tumors or metastases, on a stable dose
* Aprepitant for management of nausea and vomiting
* Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
* Patients with Charcot-Marie-Tooth disease
* A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
* Patients being treated on a Children Oncology Group (COG) clinical trial, that does not use the infant dosing tables for vinCRIStine are not eligible for this study.
* Patients receiving a modified dose (\< 1.5 mg/m\^2) of vinCRIStine due to prior toxicity
* Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study
Primary outcome measure(s)
Area under the concentration time curve for the elimination phase (AUCelim) by age group — Up to 24 hours post vincristine dose Estimate (95% CI) of the mean area under the concentration time curve for the elimination phase assessed at 0, 2, 6-8, and 18-24 hours after vinCRISTine dose by age group.
Trial sites (29)
Facility
City
Region
Status
Children's Hospital of Alabama
Birmingham
Alabama
Children's Hospital Los Angeles
Los Angeles
California
Children's Hospital of Orange County
Orange
California
UCSF Medical Center-Mission Bay
San Francisco
California
Children's Hospital Colorado
Aurora
Colorado
Children's National Medical Center
Washington D.C.
District of Columbia
Lurie Children's Hospital-Chicago
Chicago
Illinois
University of Chicago Comprehensive Cancer Center
Chicago
Illinois
Riley Hospital for Children
Indianapolis
Indiana
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Maryland
Dana-Farber Cancer Institute
Boston
Massachusetts
C S Mott Children's Hospital
Ann Arbor
Michigan
University of Minnesota/Masonic Cancer Center
Minneapolis
Minnesota
Washington University School of Medicine
St Louis
Missouri
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
New York
New York Medical College
Valhalla
New York
Duke University Medical Center
Durham
North Carolina
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Nationwide Children's Hospital
Columbus
Ohio
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
Pennsylvania
Saint Jude Children's Research Hospital
Memphis
Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville
Tennessee
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Texas
Cook Children's Medical Center
Fort Worth
Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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