New trials in adult AML have been initiated in the West Midlands. These trials have been supported by an ECMC. In addition the ECMC have provided laboratory support to develop a new immunoassay for treatment response. The Valaza trial opened in 2009 and after recruiting 17 patients, the findings have been submitted for publication. The Ricaza trial involving patients with AML following bone marrow transplantation, opened in July 2009 (recruited 6 patients). Two new assays for the tumour associated antigens known as cancer testis antigens have been developed, and will help us evolve patient specific therapies for this important disease.

The Birmingham ECMC has supported the establishment of a national trials network for rare paediatric cancers. Three trials are open for recruitment: CLOUD (Phase 1 Dose escalation study of Clorafabine in combination with liposomal daunorubin in childhood and adolescent AML) has already recruited five patients, a pilot study of less daunorubin (CEP-801) in young patients with relapsed refractory myeloid leukaemia is in the advanced stages of development. The third trial FOREST has been approved for funding from CTAAC in December 2009 and is in set up.

Phase 1 studies of vaccine grade dendritic cell preparations have been completed. A second vaccine study for the treatment of EBV positive malignancies is also recruiting in UK and Hong Kong. Samples are currently undergoing analysis for the T cell response to the vaccine. The results of our Phase I/II trial of a replication defective adenovirus expressing nitroreductase and CB154 was published in 2009. The gene therapy programme in Birmingham is progressing. Agreement for large scale virus manufacture has been reached (commencing 2010). A Phase 1 clinical trial in patients with hormone refractory prostrate cancer will commence early in 2011.

In collaboration with the University of Birmingham and UHB Trust we are currently establishing a licenced biobank. Banked samples from almost 1,000 cancer patients are now available for study. In addition matched fresh frozen sample collections in colorectal cancer and oesophageal cancer are ongoing with (over 200 samples). The success of the biobank has already led to new biomarker discovery programmes. Proteomic studies have identified serum biomarkers for upper GI malignancy and the identification of serum and urinary biomarkers of colorectal cancer risk have both been published in the last 12 months.

The National trials network for rare paediatric cancers is a notable success and has been established in the last year. A symposium specifically looking at trial design for rare tumours is being supported in the Spring 2010. In collaboration with the Leeds ECMC, we are successfully undertaking a novel translational research programme looking at markers of responsiveness to neoadjuvant therapy for colon cancer. Finally a novel biomarker study in inflammatory bowel disease related cancer is being undertaken between the Birmingham ECMC and Barts.

Patient involvement in experimental cancer medicine is a key area of research and development for all the ECMCs. In Birmingham we have completed a patient information DVD related to one of our trials. It is hoped that this will improve communication and recruitment. This will be evaluated in patients and research teams over the next 12 months.