These cell units are prepared in the laboratory in order to “teach” the lymphocytes (cells responsible for the defence of the organism) to combat the tumour cells of advanced solid tumours. Amongst these are recurrent and/or metastatic sarcomas and tumours of the central nervous system (SNC).
The University Hospital of Navarra is the promoting research body and the only centre organising such trials, recently authorised by the Spanish Ministry of Health and the goal of which is to test the safety and efficacy of this treatment. The Carlos III Health Institute is taking part in its financing.
Sarcomas and criteria of inclusion
Sarcomas are malign tumours that arise in bone or the soft tissue of the organism, such as cartilage, fat, muscle or blood vessels, amongst others. Its highest incidence rate is detected during adolescence and young adulthood. After good response to the first line of treatment, the sarcoma may recur (reappear in the same location) or metastasis (appearing in organs or structures other than the primary location).
This is why, the criteria for inclusion of patients to be treated with this experimental therapy involves the age range of 3 to 40. Moreover, the new treatment will also have access to patients with high-grade tumours that affect the central nervous system.
Initially, the Hospital team viewed the administration of this treatment for the first patients as authorised compassionate use with promising results. These first patients were the precursor for the I-II clinical trials stage which are now under way and with which the safety and efficacy of this therapy can be tested in a total of 10 patients.
The research team is made up of doctor Ana Patiño from the Department of Paediatrics and lead researcher and doctor Luis Sierrasesúmaga, specialist and Professor of Paediatrics and member of the Area of Musculo-skeletal Tumours at the Hospital. The task of the Area of Cell Therapy is co-ordinated by doctors Susana Inogés and Ascensión López Díaz of Cerio, researchers at the Hospital and at the Centro de Investigación Médica Aplicada (CIMA) of the University Hospital of Navarra. Also part of the team is doctor Marta Alonso, Director of the Biological Therapies for Brain Tumours Laboratory at CIMA.
Goal of the trials
According to doctor Patiño, the objective of the research lies in “providing a therapeutic tool – the effectiveness we wish to test and the toxicity of which we can discard- for patients that, according to the conventional protocol for the disease, have very low possibilities of survival”. Patients with SNC sarcomas or tumours primarily treated with conventional therapies have a 70% of the treatment proving effective. However, the specialist points out, if metastasis or recurrence occurs, “survival is very low due to a very high morbidity, given that what is involved are patients that have previously received high doses of various treatment of chemotherapy, radiotherapy and surgery – at times very aggressive”.
Treatment with autologous dendritic cell vaccines is aimed at the patient’s own immune system “developing a specific immunovigilance against the tumour cells of the tumour itself”. This involves a therapy that, due to its characteristics, is not suitable for the control of large quantities of tumour. This is why patients that can be part of the clinical trial are those who have an operable recurrent or metastatic tumour, “in that surgery can reduce the tumour tissue to a minimum size, at the same time providing sufficient sample in order to draw up the treatment”, stressed doctor Patiño.
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