Achievements
Expansion of portfolio
The Liverpool ECMC has 62 trials in its portfolio, with 11 trials adopted since January 2009. There are also currently 10 trials awaiting adoption.
Expansion of the Management Board and recruitment of nurses
The Liverpool ECMC Management Board comprises of 31 members. One Research Practitioner has been in post since 2008 and has successfully integrated with clinical teams, MDTs and the Cancer Research Network promoting the Liverpool ECMC to colleagues and patients and significant training needs have been addressed. The second Research Practitioner post is currently being advertised for recruitment. In November 2009, a mass spectrometrist took up post and will work exclusively in the Liverpool ECMC GCLP laboratories, providing support to ECMC adopted trials.
Opening of Good Clinical Laboratory Practice (GCLP) laboratories
The GCLP laboratories, which opened in summer 2008, have undergone further development and expansion enhancing storage capacity and enabling new forms of trial sample analysis. In addition to the main GCLP laboratory, the facility now comprises the new Molecular Biology laboratory (housing the Lightcycler480 and other DNA analysis equipment); the Microbiology laboratory (housing new microbial culture incubators and facilities for microbial manipulation); the Instrument Room (housing the Qtrap 5500 Mass Spectrophotomer and FACSCANTO 6 colour analyser); and a new storage facility which doubles the biobanking capacity of the facility. The Pharmagraph Environmental Monitoring System has been extended to allow for increased biobanking capacity and to monitor the four new microbial culture incubators. The Laboratory Information Management System (LIMS) has been constructed, installed and is currently undergoing testing and validation. This system will be rolled out for the tracking of samples from all trials coming into the GCLP Facility. Standard Operating Procedures (SOPs) are in place for all aspects of the GCLP Facility with new SOPs developed according to need. A Quality Assurance audit programme has been initiated and is progressing. Procedural Documents and QA SOPs are in place and are developing. An in-house GCLP training programme has been initiated to ensure continuous experimental training and development for the LECMC GCLP core staff.
Integration of Biobanking Capabilities
The Liverpool ECMC has continued over the past 12 month to receive and store samples from trials in the following cancers: Chronic Lymphocytic Leukaemia (AdMIRe and ARCTIC), follicular lymphoma (PACIFICO) Pancreatic (ESPAC1, 3, and 4, TeloVac), Head and Neck (HOPON), Uveal melanoma (ITEM), and from a variety of other cancer types (LIV C3). New trials are also in set-up such as: Uveal melanoma (SUAVE), Chronic Lymphocytic Leukaemia (CLL210), Endometrial cancer (STS Hormone Inhibitor), Mantle Cell Lymphoma (SPRINT), Advanced Pancreatic Cancer (PERU), Carcinoma of the Penis (Penile TPF). Other tissue resources integrated into the Liverpool ECMC GCLP network include 1) The Liverpool Cancer Tissue Bank Research Centre which holds >16,000 paraffin samples and >12,850 frozen samples from patients representing 18 different cancer types, tissue microarrays for Breast, Colorectal, Head and Neck, Pancreatic, Nasal and Renal cancers; 2) The Liverpool Lung Cancer project which holds specimens on over 10,000 individuals; 3) The University of Liverpool Leukaemia Bank which holds >40,000 vials of patient cells, collected over 20 years. Material stored includes leukaemia cells, plasma and germline DNA from 485 local patients diagnosed with chronic lymphocytic leukaemia, along with the clinical data for these patients. Serial patient samples and clinical data are also stored for chronic myeloid leukaemia (CML) (230 patients) as well as a variety of other leukaemias and lymphomas (161 patients). The bank is the custodian of trial material for the NCRI and securely stores 190 samples from 4 trials.
Activities are set to expand further with the start of a MERCK sponsored PET-CT trial, MERCK PN144, for which all translational samples will be transferred to Liverpool ECMC GCLP laboratories for storage/analysis. A similar situation exists in relation to the CLL210 trial, which is also due to open in spring 2010.
Development of New Cancer Research UK Applications and Phase I/II studies
During the past 12 months, funding has been awarded by Cancer Research UK and the NCI-NTRAC for a phase IIa feasibility trial, IMCAT: Immunotherapy for squamous cell carcinoma of the head and neck by Trans-immunisation. This is currently in set-up. Funding has also been awarded for ITCL: a phase II evaluation of high dose chemotherapy and autologous stem cell transplantation for intestinal T-cell lymphomas. The LIVC3 trial has entered into collaboration with Stanford University, USA to compare techniques for the detection of circulating tumour cells in peripheral blood.
Closure/completion of trials
During the past 12 months, the following trials have closed to recruitment and are currently in follow up:
MO20927: An open-label study to characterize the safety and response rate of MabThera (Rituximab) plus chlorambucil in previously untreated patients with CD20-positive B-cell chronic lymphocytic leukaemia. This trial closed to recruitment on the 30th November 2009.
SHIELD (VEPEMB): A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years. This trial closed to recruitment on the 31st August 2009.
Syndax: A Phase 2, Multicenter, Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women with ER+ Breast Cancer Whose Disease is Progressing. This trial closed to recruitment on the 1st August 2009.
Hosted the New Perspectives In Head & Neck Premalignant Lesions Symposium 27/02/2009
Following discussions within the NCRI H&N CSGs about priorities for biomarker studies, a national meeting "New Perspectives in H&N Pre-malignant Lesions" was hosted by the LECMC on 27th February 2009, in Liverpool. Delegates (from UK and Europe) totalling 125 from a variety of disciplines presented their latest findings and discussed areas of greatest clinical need. Keynote lectures were warmly received given by Dr Ruud Brakenhoff, Research Director of the Lung & H&N group in VUMC Amsterdam and Dr Jay Boyle from Memorial Sloan Kettering Cancer Centre New York. It is hoped that a further meeting on this theme will be arranged by the Newcastle team and that further themed H&N symposia will be hosted within Liverpool in future years.
Ocular Oncology Group Meeting:
Dr Sarah Coupland is organising the Ocular Oncology Group Meeting to be held in Liverpool on 18th – 20th March 2010.