5-FU in relapsed Ependymoma v2.0
Research type
Research Study
Full title
Pilot institutional study evaluating 5-fluorouracil following radiation therapy in children and young adults with relapsed/refractory ependymoma.
IRAS ID
149833
Contact name
Fernando Carceller
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2014-001470-34
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Ependymoma is the third most common tumour in childhood. Around one third of these children will experience relapse and for them treatment options are very limited, with long-term survival rates below 30%. Recent laboratory research has highlighted 5-fluorouracil (5-FU); a chemotherapy drug which has been used for many years in certain adult cancers, and for which safety information is available. 5-FU has recently demonstrated promising activity against ependymoma cells in the laboratory.
Hence, this study aims to evaluate whether 5-FU given into the vein, as a bolus (quick push) followed by continuous infusion over 48 hours, is effective and tolerable in a small number of children and young adults with ependymoma which has recurred following previous standard treatment. Participants should be aged 1-24 years and should have been treated previously with radiotherapy.
This study will also evaluate new techniques of magnetic resonance imaging (MRI), generically called “functional” MRI, to assess changes induced by 5-FU in the ependymoma.
If the results of this pilot study are encouraging, it will be implemented in a larger trial conducted jointly with other specialist centres such as ours.REC name
London - Central Research Ethics Committee
REC reference
14/LO/1553
Date of REC Opinion
30 Oct 2014
REC opinion
Further Information Favourable Opinion