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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05359237




Registration number
NCT05359237
Ethics application status
Date submitted
28/04/2022
Date registered
3/05/2022
Date last updated
22/03/2024

Titles & IDs
Public title
Vincristine Pharmacokinetics in Infants
Scientific title
A Pharmacokinetic Study of VinCRIStine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods
Secondary ID [1] 0 0
NCI-2022-03576
Secondary ID [2] 0 0
PEPN22P1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematopoietic and Lymphoid Cell Neoplasm 0 0
Malignant Solid Neoplasm 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Biospecimen Collection
Treatment: Drugs - Vincristine

Observational (SOC vincristine, biospecimen collection) - 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.


Treatment: Surgery: Biospecimen Collection
Undergo collection of blood samples

Treatment: Drugs: Vincristine
Given IV per standard of care
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the concentration time curve for the elimination phase (AUCelim) by age group
Timepoint [1] 0 0
Up to 24 hours post vincristine dose
Secondary outcome [1] 0 0
Intra- and inter-age coefficient of variation (CV)
Timepoint [1] 0 0
Up to 42 days

Eligibility
Key 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

- 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
Minimum age
No limit
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05359237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emily Blauel
Address 0 0
Pediatric Early Phase Clinical Trial Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05359237