13-cis-retinoic acid monitoring study

• Research type

  Research Study

• Full title

  Pilot study to investigate the feasibility of 13-cis-retinoic acid pharmacokinetic monitoring in high-risk neuroblastoma patients

• IRAS ID

  3741

• Contact name

  Gareth Veal

• Sponsor organisation

  University Hospitals of Leicester NHS trust

• Eudract number

  2008-003606-33

• ISRCTN Number

  n/a

• Research summary

  For many drugs used to treat cancer in children, currently used dosing regimens can lead to large variations in drug levels in the plasma (blood) of patients following drug administration, and hence variations in drug exposure. The drug 13-cis-retinoic acid (isotretinoin) is currently used for the treatment of children with neuroblastoma, a tumour of the sympathetic nervous system frequently originating in the abdomen, neck or thorax. We know that there are particularly large variations in 13-cis-retinoic acid exposures between individual patients following conventional dosing. Indeed, there are concerns that those patients with lower drug concentrations may be less likely to respond to treatment. This is particularly the case for infants and very young children for whom the active drug has to be removed from the capsule in order to allow administration. The hypothesis being tested in the current study is that by implementing 13-cis-retinoic acid dose modification, based on individual patient plasma concentrations and observed toxicity on the first course of treatment, we can minimise the level of variation on additional courses of treatment. This will help to ensure patients are not exposed to plasma concentrations unlikely to be beneficial, and hence reduce the likelihood of patient relapse. Any high-risk neuroblastoma patient who is receiving 13-cis-retinoic acid as part of their treatment is eligible for the study. This involves the collection of 5 blood samples, following treatment on one or more study days, for analysis of drug levels. Treatment on additional courses of 13-cis-retinoic acid will be guided by plasma concentrations determined in individual patients.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/55

• Date of REC Opinion

  15 Jan 2009

• REC opinion

  Further Information Favourable Opinion