Brain tumour clinical trial title

My-CRA, Liquid 13 Cis Retinoic Acid (Study ID: 33256)

Brain tumour type




13-CRA is used to treat some children with Neuroblastoma and other cancers, usually during the maintenance phase. Currently 13-CRA is only available in gelatin capsules. So if a younger child cannot swallow capsules then there is a need to cut them open them and squeeze the contents onto a spoon or into foods. Using this extraction method can result in unpredictable and variable levels of 13-CRA absorbed into the body. Nova BioPharma are developing a liquid formulation of 13-CRA, to try to overcome the difficulties associated with having to cut open gelatine capsules. This trial aims to compare the new liquid form of 13-CRA with the capsule form (currently prescribed). This trial will measure the levels of 13-CRA in the blood (pharmacokinetics) after taking 13-CRA. The trial will check that similar blood levels of 13-CRA are reached whether the patient receives it from extracted capsules or from the new liquid. This trial will provide doctors with confidence that the new liquid can be used safely in children who need 13-CRA. At the same time we will collect information on the safety of 13-CRA use in patients for both the liquid and capsule and how easy the liquid is to use and what it tastes like by asking patients and/or parents to fill in a questionnaire. Approximately 15-20 patients, both male and female, aged 0 years to < 21 years of age will be recruited. All patients requiring at least two cycles of 13–CRA therapy will be eligible. The pharmacokinetics will be evaluated over two months. Patients will be randomised to either liquid or capsule formulation in month 1 and then then cross-over to the alternative formulation in month 2. The dose administered will be 200mg/m2/day. After the study patients will revert to standard therapy. The trial will be undertaken in approximately 8-11 NHS Trusts.

Date added: 12th January 2019

Open/Closed: Open

Trial ends: March 2019


Nova Laboratories Ltd

Contact details

Prof Deborah Tweddle :
Martin House
Gloucester Crescent
LE18 4YL
Telephone: 01912824068

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