OPPORTUNE Trial results presented at SABCS

OPPORTUNE Trial results presented at SABCS

Professor Schmid at the world's largest Breast Cancer meeting: the San Antonio Breast Cancer Symposium

FDA approves new bladder cancer immunotherapy

FDA approves new bladder cancer immunotherapy

Based on results of a trial led by researchers at Barts - EU approval pending

Centre for Experimental Cancer Medicine

The Centre provides design and management support for all trials in cancer patients including national, pharmaceutical and investigator-led studies. We have over 120 trials open at any one time, and recruit around 600 patients into studies every year.  We are supported by a £2M grant from Cancer Research UK and the Department of Health to undertake early phase (phase I/II) clinical trials. We focus particularly on biological therapies including antibodies, viral gene therapies and cell-based therapies.

Incorporated into the Centre is the Orchid Clinical Trials Unit, which is a team supported by the Orchid Charity and focuses on hypothesis-based phase II clinical trials in patients with prostate, testis and penile cancers.

The North-East London National Cancer Research Network is affiliated to the Centre and receives funding from the NIHR to provide research nurses, trial coordinators and data managers for randomised clinical trials across the network in North-East London.

Group Leaders in the Centre

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Life in the Centre

Get a sense of what life is like in the Centre:

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Staff

The Centre offers support for clinical trials at all stages:

Biostatistics Support to assist in the optimal design of studies as well as subsequent management and interpretation of data.

Quality Assurance Management for the development, maintenance and continuous improvement of Quality Management systems (Standard Operating Procedures etc), staff training, liaison with Research and Development to ensure regulatory compliance, monitoring and audit of trials.

Clinical Trials Coordinators for management of the clinical trial portfolio, development and maintenance of central and study site files for ongoing clinical trials; preparation of  protocols, study documents, study reports and related regulatory submissions; and coordination of all pre-initiation administrative activities, as well as preparation of study-specific tools

Research Pharmacist who is responsible for all oncology clinical trials, and maintains the treatment protocol binders, supports staff in the preparation of study documentation.

Research Nurses who work with tumour-specific Multi-Disciplinary Teams to increase recruitment of patients into trials, and are involved in the management of patients and trial data.

Database Programmers and Administrators for the development and programming of clinical trials databases, including database set-up, eCRF generation and data analysis. {tab Results and Discoveries}

Clinical trials infrastructure and governance

We ensure that investigators have a completely consistent process for the establishment of all clinical trials, from phase I to phase III/IV. We can take proposals all the way from initial idea, through funding application, trial initiation and set-up, to trial completion and data analysis.

The Centre has a good record of MHRA inspections, and the Centre and its Tissue Bank were highly commended by the Human Tissue Authority. In addition, JACIE (Joint Accreditation Committee of the ISCT and EBMT) has not only accredited Barts as a centre for bone marrow transplantation, but also noted an ‘unparalleled’ level of research excellence in the field of transplantation.

Increasing recruitment and increasing the number of open trials

There are currently over 120 cancer trials open to recruitment and around 600 patients are recruited into studies each year. This means that 1 in 5 of our cancer patients are now able to participate in a clinical trial, and we aim to increase this still further.

Investigator-initiated academic studies

A series of investigator-led, academically funded studies has been initiated over the past 4 years, including DEPICT, ADAM, DB4 and MARALL, all funded by Cancer Research UK, and CNTO328, funded by the MRC.

ADAM is an excellent example of true translational research: the pre-clinical laboratory data underpinning the trial has been generated by Dr Peter Szlosarek as part of his CR-UK Clinician Scientist Fellowship and the trial funding is provided by a separate CTAAC grant, with collaboration from Polaris Pharmaceuticals.

COSAK (cediranib and saracatinib in renal cancer) is another example of a CTAAC-funded phase II study that was developed and led from this Centre.

Phase I studies

In 2010 four phase I trials opened:
A first-in-man study of an Aurora kinase B inhibitor
A study of a Notch inhibitor in pancreatic cancer
A study combining dovitinib and everolimus. in renal cancer
A phase I trial of elacytarabine in relapsed AML

Imaging

Imaging is a core strength of the Centre, which is equipped with state of the art clinical imaging technology to complement the leading edge facilities for preclinical imaging in the Centre for Molecular Oncology & Imaging. We are presently running a Positron Emission Tomography (PET) scanning study with a demobesin-4 probe developed in house in patients with advanced prostate cancer, funded by Cancer Research UK’s New Agents Committee. Another study, run in collaboration with the Cambridge ECMC is defining the FDG-PET parameters for response and non-response in relapsed ovarian cancer.

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