Vincristine Pharmacokinetics in Infants
Vincristine Pharmacokinetics in Infants
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.
Pediatrics
N/A
Children
Not Available
Not Available
Borinstein, Scott
International
Vanderbilt University
03-21-2023
Eligibility
up to 12 Years
ALL
false
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
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
Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m\^2 dose level
Any disease status
Any disease status
Patients must have a Lansky performance status of 50 or higher
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 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 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 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
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
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
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
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
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
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.
Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
Patients with Charcot-Marie-Tooth disease
Patients with Charcot-Marie-Tooth disease
A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
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 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 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
Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study
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
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
Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m\^2 dose level
Any disease status
Any disease status
Patients must have a Lansky performance status of 50 or higher
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 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 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 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
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
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
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
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
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
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.
Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
Patients with Charcot-Marie-Tooth disease
Patients with Charcot-Marie-Tooth disease
A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
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 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 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
Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study
