The study, involving doctors and cancer scientists in Southampton, America and Germany, will boost the body's immune system to kill off neuroblastoma, one of the most common childhood cancers.
The Phase 1 trial is funded by UK charities Solving Kids' Cancer (Europe), JACK and US charities Solving Kids' Cancer and Band of Parents. It will be one of many to be conducted at the University of Southampton's Centre for Cancer Immunology, which is the UK's first and only centre dedicated to cancer immunology research. The centre recently opened at University Hospital Southampton, thanks to the University's £25m fundraising campaign.
Neuroblastoma affects around 100 children - mostly under the age of five - in the UK every year and develops from immature nerve cells. It usually starts as a tumour in the abdomen or chest, however, in many children, it spreads to other places in the body such as the bones and bone marrow.
In those cases, less than half of patients are cured despite intensive treatment which includes surgery, chemotherapy, radiotherapy and stem cell transplants.
More recently, a form of immunotherapy known as anti-GD2, which uses antibodies to lock onto cancer cells so the immune system can find, fight and destroy them, has shown the potential to improve survival rates.
This new study, led by Dr Juliet Gray, Associate Professor of Paediatric Oncology at the University of Southampton, involves combining mIBG, a special form of targeted radiotherapy which delivers radioactive iodine directly to neuroblastoma cells, with two different antibody therapies for the first time.
One of these therapies, Nivolumab, has shown exciting results in adult cancers. It blocks a harmful protein called PD-1 and gives patients' own immune cells a boost so that they can be set free to kill tumour cells.
The researchers will give Nivolumab alongside the currently-used anti-GD2 to target specific cancer cells while protecting normal healthy cells.
The trial will be run from four centres - the University of Southampton's Centre for Cancer Immunology, UCH, Madison Children's Hospital, Wisconsin, and the University of Greifswald, Germany. It is also the first trial to be sponsored by University Hospital Southampton NHS Trust.
"Immunotherapy with anti-GD2 has been shown to increase the number of children with neuroblastoma who stay in remission and has become a standard component of treatment - but sadly a large number of children still relapse and die from their disease," explained University of Southampton's Dr Gray who is also a consultant paediatric oncologist at Southampton Children's Hospital.
"Work in the laboratory has shown that combining these types of antibodies with radiotherapy is potentially a very powerful way of eradicating neuroblastoma tumours and these three different therapies appear to work together to generate strong, protective immunity to the tumour."
She added: "This trans-Atlantic trial will be the first time they have been tested together and we are hopeful the combination of treatments will substantially improve the cure rate of children with this form of cancer."
Stephen Richards, CEO of Solving Kids' Cancer (Europe), said: "Cutting-edge clinical trials offer real hope for children with high-risk neuroblastoma and their families. The numbers of children affected are small, so funding collaborative international research is the only way we will improve survival rates and find a cure for this devastating disease."
The researchers plan to give an initial course of mIBG-targeted radiotherapy followed by Nivolumab and anti-GD2 over a period of six months. Although the initial stages of the treatment process will require children to be in hospital, it is hoped that the therapy will be well tolerated and will eventually be delivered largely on an outpatient basis.
The trial's objective is to ensure the combination is safe to deliver to children with neuroblastoma in order to develop further studies to compare it with current treatments.
Notes to editors
1. UK charities Solving Kids' Cancer (Europe) and JACK, and US charities Solving Kids' Cancer and Band of Parents each contributed $125,000 to the $500,000 Phase 1 trial.
2. Peter Johnson, Professor of Medical Oncology at the University of Southampton, is available for interview. To request an interview please contact the University's media relations team.
3. The University of Southampton drives original thinking, turns knowledge into action and impact, and creates solutions to the world's challenges. We are among the top 100 institutions globally (QS World University Rankings 2019). Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 24,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, the University helps students on a journey of discovery to realise their potential and join our global network of over 200,000 alumni. http://www.
4. University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England, with an annual spend of £700 million at three sites across the city of Southampton. It provides hospital services for 1.9 million people living in Southampton and southern Hampshire and specialist services including neurosciences, respiratory medicine, cancer, cardiovascular, obstetrics and specialist children's services to more than 3.7 million people in central southern England and the Channel Islands.
5. Building on its cancer immunology research expertise and recent successes in immunotherapy trials, the University of Southampton has raised 25m to build the UK's first dedicated Centre for Cancer Immunology at Southampton General Hospital. The Centre, which opened at Easter 2018, is the first of its kind in the UK and brings together world-leading specialists in a unique state-of-the art centre. The aim of the new Centre is to accelerate research progress, conduct more clinical trials and save more lives from cancer. The University is continuing to fundraise for the Centre, supporting the pioneering scientists that will drive forward the research to find more cures for cancer. Find out more about it at: http://www.
6. Supporting quotes available. Richard Brown CEO of J-A-C-K, (Joining Against Cancer in Kids), said," Despite the best intentions and energies of individuals the progress toward developing better treatments for children with neuroblastoma has been too slow for too long. The trial pioneers extensive partnership between clinical centres and charities at an international level. J-A-C-K believes that such collaborations can bring the hope of finding a cure ever nearer."
7. Supporting quotes available: "If we are going to fulfil our mission and advance cures for children with the most fatal cancers, there simply is no better approach than funding international clinical trials," said Scott Kennedy, Executive Director, Solving Kids' Cancer US. "It means there are more powerful researchers behind the study, greater accrual, increased data collection, faster results and wider availability to the children who need it."
For more information
Josh Bell, Media Relations Officer, University of Southampton, Tel: 02380 593212/07717 801141, Email: email@example.com.