Assessment and optimisation of carboplatin exposure in pediatric oncology patients using different markers of kidney function

Assessment and optimisation of carboplatin exposure in pediatric oncology patients using different markers of kidney function - Carboplatin pharmacokinetics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37073

Enrollment

Registered

2008-07-14

Start date

2009-01-09

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer Malignancy

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Carboplatin therapy, weight above 2.5 kg, central venous line for bloodsampling

Exclusion criteria

Exclusion criteria: Weight below 2.5 kg, no central venous access for bloodsampling

Design outcomes

Primary

Measure	Time frame
Using the NONMEM software (version VI level 1.1, GloboMax LLC, Hanover, MD) a on-linear mixed-effect population pharmacokinetic model will be calculated [10]. In this model the concentration of free platina in plasma will be used as a measure of the plasma carboplatin concentration. Both interindividual (IIV) and interoccasion variability (IOV) will be modelled. At least three different models for the description of the relationship between carboplatin clearance, plasma creatinine and cystatine C will be tested: The hypothesis that there is not relationship between carboplatin clearance and the concentration of the kidney function paramers will be used as reference. This will be compared with models including plasma cystatine C or creatinine or both. The area-under-the-concentration-time-curve (AUC) as a measure of effective carboplatin exposure will be calculated from carboplatin clearance and dose.	—

Measure

Time frame

Using the NONMEM software (version VI level 1.1, GloboMax LLC, Hanover, MD) a on-linear mixed-effect population pharmacokinetic model will be calculated [10]. In this model the concentration of free platina in plasma will be used as a measure of the plasma carboplatin concentration. Both interindividual (IIV) and interoccasion variability (IOV) will be modelled. At least three different models for the description of the relationship between carboplatin clearance, plasma creatinine and cystatine C will be tested: The hypothesis that there is not relationship between carboplatin clearance and the concentration of the kidney function paramers will be used as reference. This will be compared with models including plasma cystatine C or creatinine or both. The area-under-the-concentration-time-curve (AUC) as a measure of effective carboplatin exposure will be calculated from carboplatin clearance and dose.

—

Secondary

Measure	Time frame
- Assessment of effective carboplatin exposure in current pediatric treatment protocols. - Relationship between effective carboplatin exposure and therapy-related complications, which will be assessed using the standard procedures of the individual treatment protocol (blood count, plasma creatinine and cystatin C, audiometry) - Relationship between effective carboplatin exposure and DNA-adducts as measure of carboplatin action on a cellular level.	—

Measure

Time frame

- Assessment of effective carboplatin exposure in current pediatric treatment protocols. - Relationship between effective carboplatin exposure and therapy-related complications, which will be assessed using the standard procedures of the individual treatment protocol (blood count, plasma creatinine and cystatin C, audiometry) - Relationship between effective carboplatin exposure and DNA-adducts as measure of carboplatin action on a cellular level.

—

Countries

Netherlands

Outcome results