Status:
ACTIVE_NOT_RECRUITING
Vincristine Pharmacokinetics in Infants
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
Up to 12 years
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To validate body surface area (BSA)-banded infant dosing tables by comparing vinCRIStine drug exposure, defined as the area under the concentration-time curve for the eliminatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05359237
Start Date
November 16 2022
End Date
December 31 2025
Last Update
November 4 2025
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158