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Tayside oesophageal cancer trial recruiting soon thanks to team’s ‘very speedy turnaround’
28th March 2024
A new cancer trial is expected to open for recruitment soon in Tayside thanks to the efforts of a multi-disciplinary team of NHS and university experts which sponsor Cancer Research UK (CRUK) has praised for its swift action and high level of coordination
The MAGE Vaccine Trial is aiming to treat squamous cell carcinoma of the oesophagus through the study of two genetically modified vaccines which may help the immune system recognise and attack particular proteins on cancer cells and kill them.
As an early phase trial, the primary aim is to determine the safety of these new vaccine therapies alongside standard treatments of chemotherapy and immunotherapy.
Now, thanks to preparatory work which saw a group of NHS Tayside and University of Dundee specialists quickly coming together to form the Advanced Therapy Gene Modification Safety Committee (ATGMSC), recruitment will open in April.
The creation of an ATGMSC is a critical independent review process required to meet safety review and use of genetically modified products in a clinical setting.
Trial sponsor CRUK said it took just six weeks from sending out their Local Information Pack to having a Site Initiation Visit (SIV), preceded by the ATGMSC issuing their approval which allowed Confirmation of Capacity and Capability for the site to be confirmed.
CRUK applauded “a very speedy turnaround time” while calling it “something we don’t often see with early phase trials”.
They added: “The team have been very engaged and responsive throughout the process; answering queries and completing actions in a timely manner.”
Tayside Medical Science Centre (TASC) – which delivers academic and commercial clinical research support services for NHS Tayside and University of Dundee – has played a key role throughout with the trial being led by its Director, Professor Russell Petty.
Senior R&D Manager at TASC, Dr Steve McSwiggan said: “Cancer vaccines are entering clinical trials across the globe as an exciting potential new approach to treatment.
“It is fantastic that the team can contribute to the development of innovative new treatments like this and offer these opportunities to eligible patients under our care in NHS Tayside.
“It takes a lot of commitment and collaboration to make these trials available, and I’m really proud of the professionalism of the Tayside team and the collective effort put in to make this a high priority.
“We collaborated with, developed, and set up an ATGMSC based on a similar committee in Edinburgh who shared their learning and documentation with us. Simultaneously, we applied for and registered NHS Tayside as a site capable of conducting genetic modification studies with the Health and Safety Executive both now and in the future.
“The whole process and set up was done in a matter of weeks. We placed considerable focus on it locally across a multi-disciplinary team, putting two research staff through Biological Safety Officer (BSO) training so we have developed some future capacity in this area.”
He added: “We received good feedback from the sponsor on how we guided them along. Collaboration with colleagues in the Clinical Research Facility and ATGMSC in Lothian was critical in expediting that.
“It is testament to the partnerships we have across Scotland – we really work together to make research happen and to present those opportunities across all sites.”
Professor Russell Petty said: “The squamous cell carcinoma subtype of oesophageal cancer affects socioeconomically disadvantaged populations disproportionally and there has been much less clinical trial and research focus placed on it compared to other tumour types. It really is a ‘forgotten cancer’ – and that is why this work is incredibly important.”
Dr Valerie Godfrey, Quality Assurance Manager at TASC, said: “I was tasked with setting up the committee in NHS Tayside. I had discussions with staff at NHS Lothian who helped to direct me to bring together a range of specialists who could provide expert view of the clinical trial.
“We also had to get a BSO and managed to get two volunteers. Really intensive training was involved and I’m pleased to say we now have two qualified BSOs in the Advanced Therapies area.
“During March, the trial risk assessment was approved by the ATGMSC, and R&D acknowledged that work could commence at the site. Thanks go to the enthusiastic and engaged committee who have the same goal in recognising the importance of being able to deliver these trials in Tayside.
“We couldn’t have done it so quickly without the support of Lisa Wotherspoon, Advanced Therapies Quality and Product Manager at NHS Lothian, and Quality Assurance Lead, James Gibson from Edinburgh Clinical Research Facility.
“I’m now very excited by it all. I think it’s a very positive way ahead for Tayside and we are aiming for at least two trials per year and potentially more. Working together we can really help advance clinical research, and it’s been brilliant to see the collaboration not just in Tayside but with our trial sponsor and research teams across Scotland.”
