In the last year the Centre for Cancer Research and Cell Biology (CCRCB) in Belfast has moved to a purpose built research facility supported by GLP-standard core facilities providing expertise in clinical pharmacology, biological resources, genomics, bio-imaging and tissue pathology. The CCRCB sits adjacent to the Northern Ireland Clinical Cancer Centre (NICC), which opened in 2006 and incorporates an extensive day-hospital in addition to in-patient wards and is home to the Northern Ireland Cancer Clinical Trials Unit (NICCTU) which governs and operates all of the clinical trial-based research. The Experimental Cancer Medicine Centre is integral to both of these facilities.

The number of early phase clinical trials open or closed continues to increase significantly with a 47% since the previous report. In addition, there has been an increase of 113% and 126% in the numbers of patients screened and these entered into trials respectively. The number of patients recruited to biomarker studies has also increased to 41 (114% compared to the previous year) in the four studies open or recently closed. The expansion of early phase and biomarker studies has been developed via the ECMC funding.

• The increased demand for radiology, pathology and pharmacy support within the trials portfolio has been eased by the ECMC funding. Capacity problems have now been resolved with dedicated sessions for key individuals across these research support areas.
• The ECMC Research Nurses are an integral component in the clinical trials programme and have organised and hosted and organised one of the ECMC nurses forums in Belfast.
• The biological processing of the tissue samples will be assisted by the appointment of two further pathology technicians funded by the CR-UK Centre. Tissue collection now includes FFPE samples. HTA and MHRA compliance has been reviewed to meet the required regulations.
• The clinical pharmacology laboratory has been used to analyse samples within the clinical cancer centre.
• Promoted collaborations and enabled personnel to allow basic research labs to move into translational research

Patient accrual to clinical trials has increased significantly and there is expanding clinical trials activity in particular early phase and multicentre phase 3 studies. In 2009, we recruited cancer patients into 2 phase I and 15 phase II trials). Our ECMC leads on the following trials: (i) Phase II study to assess the safety, efficacy and tolerability of combination therapy with Velcade (Bortezomib), Adriamycin and Dexamethasone (PAD) as therapy for patients with relapsed or refractory multiple myeloma; (ii) A dose finding study of Bortezomib in addition to Epirubicin, Carboplatin and Capecitabine (ECarboX) in advanced Gastric and Gastro-Oesophageal Junction Adenocarcinoma; (iii) Rhenium & Taxotere- A phase I/II study of Combined Docetaxel and Repeated Rhenium-186 HEDP in Hormone Refractory Prostate Cancer Metastatic to Bone; (iv) Phase II Study to Assess the Efficacy, and Tolerability of Velcade (Bortezomib) as Therapy for Patients with Untreated, Relapsed or Refractory Malignant Pleural Mesothelioma; (v) A phase 1 followed by a randomized phase II study of carboplatin and etoposide with or without obatoclax administered every 3 weeks to patients with extensive stage small cell lung cancer (ES-SCLC); and (vi) A phase II multi-center, open-label, study of Nilotinib at a dose of 300mg twice daily in adult patients with newly
diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

With several key clinical academics working in an integrated manner between the clinical cancer service and the CCRCB, it has been possible to design and conduct a number of translational studies based on our own scientific discoveries, and lead from Belfast, particularly in the identification of predictive biomarkers and the application of functional imaging technologies in monitoring the response of patients to novel therapeutic agents. These include: (i) a study examining the association of serum interleukin-8 (IL-8) with response to dexamethasone in metastatic hormone-refractory prostate cancer (HRPC); (ii) isolation of circulating colorectal cancer tumour cells: A pilot study; and (iii) investigation of the use of PET-CT image fusion in the measurement of treatment response in patients with stage IIIB – IV non-small cell lung cancer treated with Docetaxel and Platinum chemotherapy. There are also a number of pharmacogenomic studies to identify predictive signatures of response to chemotherapy and prognostic markers in EORTC and US colorectal, GI and lung cancer Co-operative Group studies as well as in UK, NCRI, EORTC and ERL studies. One of these studies is part of an FDA 510K approval submission in collaboration with Almac Dx and CALGB. There are also very strong relationships with a number of pharmaceutical and biotech companies including AGI therapeutics, Almac Diagnostics, AMGEN, Astra Zeneca, Lilly, MSD, Randox Laboratories Ltd, Sanofi Aventis and Mallinckrodt

ECMC funding was pivotal to securing DEL Cross Border Initiative funding for the Cancer Bio-Informatics Unit which will focus on experimental medicine applications. The ECMC funding has significantly impacted on the success of the application to establish a tumour bank in Northern Ireland. The bio-repository and the data associated with it will be linked with other similar resources in the UK through interaction with other members of the NCRI supported Confederation of Cancer Bio-Banks. The informatics supporting the NI tumour bank will also be developed in line with all guidelines to promote the sharing of information relating to cancer research activities nationally and internationally.