Vincristine Pharmacokinetics in Infants

Recruiting at 28 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Must be taking: Vincristine

Must not be taking: Azoles, Macrolides, CYP3A4/5 inducers

Disqualifiers: Charcot-Marie-Tooth, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

83 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Emily Blauel

Principal Investigator

Pediatric Early Phase Clinical Trial Network

Eligibility Criteria

Inclusion Criteria

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

0 to 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vincristine intravenously per standard of care with blood samples collected at specified intervals

6 weeks

Weekly visits for vincristine administration and blood sample collection

Follow-up

Participants are monitored for dose modifications and pharmacokinetic analysis

42 days

Treatment Details

Interventions

• Vincristine

Participant Groups

Group I: Observational (SOC vincristine, biospecimen collection) Experimental Treatment 2 Interventions

Patients receive vincristine IV per SOC. Patients undergo collection of blood samples at baseline (before first vincristine dose), and 2, 6-8, and 18-24 hours after a dose of vincristine. Patients may also undergo collection of blood samples with a second SOC vincristine dose at the same time points.

Vincristine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vincristine for:

• Acute lymphocytic leukemia
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms' tumor

Approved in European Union as Vincristine for:

• Acute lymphoblastic leukaemia
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms' tumour

Approved in Canada as Vincristine for:

• Acute lymphocytic leukemia
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms' tumor

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+