NCCPG TDM 2018
Research type
Research Study
Full title
A Clinical Pharmacology Study to Investigate the Utility of Therapeutic Drug Monitoring in Challenging Childhood Cancer Patient Populations
IRAS ID
240311
Contact name
Deborah A Tweddle
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
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.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0384
Date of REC Opinion
23 Jan 2019
REC opinion
Further Information Favourable Opinion