Pharmacokinetic variation and toxicity in Ewing's sarcoma

• Research type

  Research Study

• Full title

  Pilot study to investigate the early prediction of toxicity following induction chemotherapy in Ewing’s sarcoma by blood-borne biomarkers and correlation with age-dependent pharmacokinetic variation

• IRAS ID

  123505

• Contact name

  Quentin Campbell Hewson

• Contact email

  Quentin.CampbellHewson@nuth.nhs.uk

• Eudract number

  2013-000052-17

• ISRCTN Number

  N/A

• Research summary

  Ewing’s sarcoma is a bone cancer most commonly diagnosed in teenagers. Current treatment stategies result in approximately 60% of patients being cured but with serious side-effects often associated with treatment. Routine tests do not accurately predict who will be cured or will experience increased side effects. By learning about what happens to the key drugs administered to Ewing’s sarcoma patients following administration, how they are broken down and what factors are important in determining response and toxicity, we will look to improve treatment strategies. This may be particularly important for teenagers and young adults, who may handle drugs differently than younger children.
  Modifying drug doses for different patient groups will allow the achievement of drug exposures which are most likely to be beneficial, whilst minimising commonly observed and often severe side-effects. As part of the same clinical trial we shall also perform a series of blood tests that predict side-effects of chemotherapy in some adult patients, to see if they are helpful in children to allow us to target those children for extra support and treatment. Improved management of cancer patients is anticipated by adjusting treatment of future patients based on differences in drug exposure and expression of biomarkers predictive of response to treatment and toxicity. Although the study focuses on children with Ewing’s sarcoma, the drugs involved in the treatment of this disease and the findings of the study will be applicable across many different types of sarcoma.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  13/NE/0225

• Date of REC Opinion

  7 Oct 2013

• REC opinion

  Further Information Favourable Opinion