A multi-centre phase II clinical trial for a pioneering new surgical technique has started in the UK, jointly funded by Samantha Dickson Brain Tumour Trust and Cancer Research UK.
The trial, called GALA-5, will involve over 60 patients who have been newly diagnosed with glioblastoma, the most common and most harmful primary malignant brain tumour in adults, with an average survival rate of just 15 months from diagnosis.
The trial will examine the tolerability and feasibility of two treatments used in combination. The first one is called 5-ALA (5-Amino-Levulinic Acid), which is converted in the body to a fluorescent chemical, making the tumour glow under ultraviolet light during surgery. This pioneering technique means that surgeons should be able to see the edges of the tumour more clearly, allowing more accurate and complete tumour removal.
- Flourescent 5-ALA showing location of glioblastoma (courtesy of Dr Colin Watts, Addenbrookes Hospital)
The second therapy is given after the tumour is removed, and involves inserting wafers impregnated with the chemotherapy drug carmustine into the cavity. Carmustine is then released locally to help kill remaining tumour cells.
The GALA-5 trial is being made possible through an innovative new partnership between Samantha Dickson Brain Tumour Trust (SDBTT), the UK’s largest brain tumour charity, and Cancer Research UK, the UK’s largest cancer charity. Last year, for the first time, the two charities collaborated to jointly fund research into brain tumours.
The trial is being led by Dr Colin Watts (HEFCE Clinical Senior Lecturer) at the University of Cambridge, where the first 4 patients have been recruited. It will be rolled out to more than 10 other centres, including King’s College Hospital and the National Hospital for Neurology & Neurosurgery (both have recently opened to recruitment), and is being co-ordinated by the Cancer Research UK & UCL Cancer Trials Centre (Cancer Institute, University College London). If the combination of the two therapies is found to be safe and effective, it will be followed by a larger phase III trial.
Dr Colin Watts said: “I strongly feel that our best opportunity to progress further is to emphasise funding of lab-based research and innovative trials and the GALA-5 trial is a significant step forward in making this a reality. I am delighted to see this partnership between Samantha Dickson Brain Tumour Trust and Cancer Research UK, which really make a difference and allow more trials and clinicians to be supported.”
Neil Dickson, Founder and Chair of Trustees of SDBTT said: “We are proud to be funding this trial, which we hope will make a real difference to the lives of people diagnosed with a glioblastoma. Brain tumour research receives a fraction of the funding of that of higher profile cancers and it is our priority to redress the balance. This is essential as figures show that advances in treatment, achieved through the dedicated work of committed researchers over the years, have had a beneficial effect. Whilst we have invested heavily in laboratory based research, and continue to do so, for us as a charity this is a significant step towards funding more clinical trials.”
Kate Law, director of clinical research at Cancer Research UK, said: “Treating brain tumours is a real challenge facing clinicians and we urgently need new treatments to help more people diagnosed with the disease. By working together we are able to fund more research and really focus on areas that are going to make a telling difference. We are already building on the success of the partnership and are looking to fund more research in the coming year.”
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