The Phase I clinical trial, CITADEL-123, has been designed by Dr Paul Mulholland, Group Leader of Glioblastoma Research Group at the UCL Cancer Institute and UCLH consultant medical oncologist.
It is open to patients who have had standard treatment, but who now have recurrent disease and are fit and well enough for treatment.
Patients will undergo resection surgery at The National Hospital for Neurology and Neurosurgery (NHNN), UCLH. As much tumour as is safe will be removed and they will then have a small medical device implanted under the scalp which connects via a small tube into the tumour area.
This tube allows the nuclear medicine team at University College Hospital to inject a drug to target the tumour, delivering small amounts of radioactivity, which should damage and hopefully kill the tumour cells. This takes place approximately 14 days after surgery and patients will have weekly injections for 4 to 6 weeks.
The drug delivers its radioisotope payload in a highly targeted way to cancer cells expressing an enzyme these cancer cells use to repair themselves. This radioisotope emits low energy electrons which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells, while sparing healthy tissue.
The trial is sponsored by Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, who received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year to undertake the Phase 1 clinical trial in patients with recurrent glioblastoma.
Dr Mulholland, the trial’s Chief Investigator, said: “We have been working with Ariceum Therapeutics for some years to develop this study. It will allow us to deliver low levels of radioactivity directly into the tumour of patients with recurrent glioblastoma. I’m very pleased that this clinical trial is now open. Potentially this is a very powerful approach and I’m already extremely happy with the results from the first patient. I’m also very proud at how my colleagues in neurosurgery and nuclear medicine have come together as a team to deliver a really novel trial.”
Paul, a 62 year old engineer, is the first patient to be recruited to the trial. He was diagnosed with glioblastoma brain cancer in December 2023. Following the standard treatment of surgery, radiotherapy and chemotherapy, Paul received the news in July this year that his tumour had become active again. Scans revealed a 50 per cent reduction in his tumour at the end of treatment on the trial.
Other clinicians instrumental in making this trial happen include colleagues at the NHNN, Ms Huma Sethi, Professor Andrew McEvoy and Ms Anna Miserocchi, who are all affiliated to UCL Queen Square Institute of Neurology and Professor Jamshed Bomanji, a nuclear medicine consultant at University College Hospital, who is Honorary Professor of Nuclear Medicine at UCL Institute of Nuclear Medicine.
The CITADEL-123 trial is being run through the NIHR UCLH Clinical Research Facility, and it is supported by The National Brain Appeal. It will be open for around eighteen months and UCLH is currently the only centre recruiting patients, with other sites due to open at a later date.
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- MRI of glioblastoma in the brain, Credit: Tonpor Kasa on iStock