Treating cancer: what research can do for patients when there are no other options

Author:Dr Eleni Tholouli

Author: Dr Eleni Tholouli

Consultant Haematologist and Director of the Adult Stem Cell Transplant Unit

Dr Tholouli’s expertise covers a wide range of haemato-oncological malignancies (leukaemia, myeloma, lymphoma) and non-malignant disorders (bone marrow failures, aplastic anaemia).

She is a member of the national Acute Myeloid Leukaemia working group and Bone Marrow Transplant Clinical Reference Group

Here, Dr Tholouli talks about the Adult Oncology Research team’s success in securing their first phase 1 studies and the potential this brings to cancer patients, where there may be no other alternative available.  Phase 1 studies investigate the effectiveness and safety of either a new experimental medicine, or a new combination of existing treatments.

Acute Myeloid Leukaemia (AML) is an aggressive cancer of the blood that can develop quickly and requires immediate treatment. AML is an advanced form of myelodysplasia, which describes a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells.  The condition most commonly affects people over the age of 60, but can occur at any age. In the UK, there are around 3000 new cases diagnosed each year.

People in Manchester are 10 times more likely to be diagnosed with cancer than in other parts of the UK.  Clinical trials are essential in the advancement of clinical care for cancer patients and I’m passionate about our work in this area

The main treatment pathway for patients with AML who are fit enough to tolerate it is intensive chemotherapy and often combined with a bone marrow or stem cell transplant.  For both transplant types intensive chemotherapy and sometimes radiotherapy are required, and can cause significant side effects and complications.

Existing treatment options are limited for older patients

For older patients or those who cannot tolerate intensive treatment, options are limited to lower dose chemotherapy, which is unlikely to result in remission but may help to control symptoms, or be palliative (end of life care).

At Manchester Royal Infirmary, we have a strong track record in delivering cancer studies and are committed to providing patients with research as an option alongside other treatments, wherever possible.

Over the past four years we have grown our phase 2 and 3 study portfolio (trialling later stage treatments in small and large groups of patients).  To facilitate our increased activity, the capacity of our research team has grown.  Today, I have a team of five research nurses and three clinical trial coordinators.

Adult Oncology Research team

Adult Oncology Research team

Our phase 1 research provides more treatment options for patients

On the back of our reputation as a top recruiter in the UK, I’m delighted to be in a position to expand our work to Phase 1 studies, in collaboration with the NIHR / Wellcome Trust Manchester Clinical Research Facility (CRF) and supported by the NIHR Clinical Research Network: Greater Manchester.  Our new partnership with the CRF combines our knowledge in cancer research with their experience in conducting phase 1 experimental trials.  As well as providing the physical space to conduct the studies, the CRF is helping to ensure that we meet the highest standards of safety and quality, and our phase 1 studies have been approved by the Trust’s Early Phase Safety Committee (EPSC), in line with Medicines and Healthcare products Regulatory Authority’s (MHRA) Phase I Accreditation Scheme criteria.

We have also trained our research nurses to provide chemotherapy to support the delivery of phase 1 studies.  So far we have secured two studies, which are sponsored by The University of Birmingham and funded by the charity Leukaemia and Lymphoma Research (LLR).

  • The Romaza study is open to patients with newly diagnosed, relapsed or refractory AML, who are unable to tolerate intensive chemotherapy. It offers the option to trial a novel application of one new and one existing treatment (Romidepsin and Azacitidine) in combination. Through this study, we aim to find a safe and effective dose of two drugs in adults with AML.
  • The Viola study is open to patients with AML, who have relapsed following a stem cell transplant (where the cancer has returned). Here, we aim to find a safe and effective dose of lenalidomide, in combination with azacitiadine.

The potential to deliver phase 1 studies, in addition to later stage trials, offers more patients hope for the future.  Through this work we are providing patients with access to treatments that wouldn’t otherwise be available.  We are also building on our knowledge and reputation as a research centre of excellence.