Northern Institute for Cancer Research

Early phase clinical trials in paediatrics

Early phase clinical trials in paediatrics

We are a clinical team working in conjunction with clinical academics and research staff to develop an early phase trial service for childhood cancer patients across the North of Britain.

About

Early Phase Trials for children and young people have historically been challenging due to the low number of patients not cured by conventional therapy spread across a range of conditions, combined with the lack of financial incentive for sponsors to test therapies in this patient group. More treatments are now becoming available but patient numbers remain low. To counteract this we have established a network (INCLuDE) consisting of all the Principal Treatment Centres in the North (Newcastle, Glasgow, Edinburgh, Belfast and Aberdeen) for the purpose of having a sufficient patient load to achieve trial recruitment and make us attractive as a region for trial sponsors to open studies. The whole network covers a population of 10 million people, with an estimated 340 new cases of cancer in the 0-18 age range. This development has resulted in substantially increased trial availability and recruitment in Newcastle, with approximately half of the patients now travelling from outside our region for trials. Substantial infrastructure investment and increasing profile will only serve to enhance our activity.

Facilities

Facilities

We are based within a Principal Treatment Centre with the most comprehensive range of therapies for children and young peoples cancer in the country. Our location at the Great North Children’s Hospital, within the Newcastle upon Tyne Hospitals Trust, makes all supportive specialist paediatric services readily available. We also benefit from clinical trial support services developed by the larger adult Early Phase trials unit. Longstanding close interaction with the Newcastle Cancer Centre Pharmacology Group and our associated Children’s Cancer study groups developing novel biological targets at the NICR are a further enhancement.

Clinical trials and translational studies

Clinical trials and translational studies

In a competitive process based on our infrastructure and scientific credentials we have successfully achieved designation as a “First in Child” centre; one of only 20 such centres in Europe. As the First in Child centre for the Northern Network we will be the site for early phase paediatric studies as they come through the Innovative Therapies for Children’s cancer (ITCC) European Consortium, which administers most of the early phase trials for children and young peoples cancer. Building from preclinical research within the NICR Chief Investigator Josef Vormoor has developed the first ever CRUK combination Alliance trial for paediatric oncology – the SeluDex study, which will open across Europe. We have engaged as a partner with Roche on their therapy pipeline being early openers of their first 2 studies. Newcastle is the highest UK recruiting site for the Merck Fosaprepitant study and the Eisai Lenvatinib study.

Publications

Vormoor B, Veal GJ, Griffin MJ, Boddy AV, Irving J, Minto L, Case M, Banerji U, Swales KE, Tall JR, Moore AS, Toguchi M, Acton G, Dyer K, Schwab C, Harrison CJ, Grainger JD, Lancaster D, Kearns P, Hargrave D, Vormoor J: A Phase I/II trial of AT9283, a selective inhibitor of aurora kinase in children with relapsed or refractory acute leukaemia: challenges to run early phase clinical trials for children with leukaemia. Ped Blood Cancer 2017, 64(6), e26351 1-4 

Moreno L, Marshall LV, Pearson AD, Morland B, Elliott M, Campbell-Hewson Q, Makin G, Halford SE, Acton G, Ross P, Kazmi-Stokes S, Lock V, Rodriguez A, Lyons  JF, Boddy AV, Griffin MJ, Yule M, Hargrave D. A phase I trial of AT9283 (a selective inhibitor of aurora kinases) in children and adolescents with solid tumors: a Cancer Research UK study. Clin Cancer Res 2015 21: 267-273

Staff

Josef Vormoor
Quentin Campbell Hewson
Simon Bailey
Geoff Shenton
Britta Vormoor

Hina Johnstone
Lisa Price
Gail Forster
Geoff Bell