Cancer Cancer
Conditions
Interventions
The trial will recruit an estimated 150 patients within defined 'hard to treat' categories. These include pre-term infants and newborns, patients with impaired kidney function or no kidneys, patients
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
0 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age <18 years. 2. Confirmed diagnosis of cancer. 3. Patient receiving a ‘non-standard’ strategy of chemotherapy delivery (see below for examples of patient groups that fall into this category).* 4. Appropriate venous access. 5. Request from the treating clinician for therapeutic drug monitoring approach to treatment. 6. Willingness to participate and written informed parental/patient consent (signed and dated). * Patients receiving non-standard chemotherapy dosing regimens will include the following groups: pre-term infants and neonates, anephric patients, patients receiving high dose myeloablative chemotherapy, patients undergoing chemoembolisation procedures, obese patients (BMI at or above the 95th percentile for children of the same age and sex).
Exclusion criteria
Exclusion criteria: Failure to meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definition of the pharmacokinetics of widely used anti-cancer drugs in defined 'hard to treat' patient populations; assessment of factors associated with pharmacokinetic variability in defined 'hard to treat' patient populations. Measured by analysis of samples from patients. Time point - end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Establishment of a national registry to provide access to data relating to the dosing of a comprehensive library of chemotherapeutic in defined 'hard to treat' patient populations. Measured by analysis of samples from patients - data published on trial website. Time point - ongoing throughout study as data become available. 2. Development of national treatment guidelines supporting the use of Therapeutic Drug Monitoring treatment strategies for patients treated in the UK and more widely. Measured by analysis of samples from patients. Time point - end of study. | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed