A Clinical Pharmacology Study to Investigate the Utility of Therapeutic Drug Monitoring in Challenging Childhood Cancer Patient Populations

Study ID: 40698
Short Title: NCCPG TDM 2018
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: CYP
Phase: N/A
Expected End Date: 30/11/2028
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Inclusion criteria to be utilised for patient recruitment; a) age < 18 years b) confirmed diagnosis of cancer c) patient receiving 'modified' chemotherapy (see below for patients who fall into this category)* d) central venous catheter in place e) willingness to participate and written informed parental/patient consent (signed and dated) f) request from the treating clinical for therapeutic drug monitoring approach to treatment * Patients receiving 'non standard' chemotherapy dosing regimens will include the following groups: - neonates and infants including pre-term infants - anephric patients - patients receiving high dose myeloablative chemotherapy and autologous stem cell rescue - obese patients (BMI at or above the 995th percentile for children of the same age and sex)

a) Failure to meet the inclusion criteria

It is particularly difficult to treat some groups of children diagnosed with cancer, including very young infants in the first weeks of life and children with poor kidney function. It can be especially difficult to know how much chemotherapy (anti-cancer drugs) to give to these children. Doctors often have to make difficult decisions about the most appropriate dose of drug, without enough scientific information to help them decide. This can mean that patients might not get enough drug or get too much, and this can be harmful in terms of causing long term health problems due to under or over dosing. Our research group is a national centre for carrying out cancer drug trials in children. Over the past 10 years we have gained a reputation for expertise in supporting the treatment of ‘hard to treat’ children through the use of therapeutic drug monitoring. This involves the measurement of drug levels in individual patients following a request from the treating clinician. A limited number of blood samples are collected following drug administration and sent to our laboratory for analysis. The results are fed back to the treating clinician who can use this information alongside information on patient response and side effects to make informed decisions regarding the continued treatment of the individual patient. Based on the positive impact on patient treatment of this approach, we now aim to conduct a study to allow the formal collection of clinical data following the treatment of these challenging patient populations. The findings of this research programme will be made available to doctors treating children with cancer about what doses of drugs to prescribe. This will positively impact on the treatment of future childhood cancer patients by providing data that will inform future dosing guidelines.

Study MapList of studies

Accessibility tools

Return to header