Urological Oncology Clinical Trials

Clinical trials

Dr Hussain (University of Liverpool) and Prof James (University of Birmingham) set out to improve outcome of organ preservation for patients with muscle invasive bladder cancer 14 years ago with a phase I study to investigate the effect of adding chemotherapy into radiotherapy treatment (Hussain et al; Annals of Oncology 2001), proceeding to phase II that suggested encouraging efficacy (Hussain et al; British journal of cancer 2004). These data led to a successful grant from CR UK for the conduct of the phase III study, which developed into the largest bladder cancer study of organ preserving treatment, and which has established a new standard of care internationally by demonstrating that adding synchronous chemotherapy to radiotherapy significantly improves local disease control for patients with muscle invasive bladder cancer opting for organ preservation. (James R, Hussain S, Hall E et al. N Engl J Med 2012;366:1477-88). The follow on TUXEDO trial (investigating the addition of cetuximab to CRT) is being led jointly by Birmingham (Prof James) and LEDDU (Dr Hussain).

Dr Hussain has also secured funding from Boehringer Ingelheim to conduct a multicentre randomised phase II neo-adjuvant study comparing Nintedanib, a triple angiokinase inhibitor (VEGF, FGF and PDGF receptors) versus placebo in addition to standard chemotherapy for patients with muscle invasive bladder cancer.

Dr. Hussain is a leading recruiter to national NCRN portfolio studies in bladder, prostate and kidney cancers.  

In collaboration with Dr. Guru Sonpavde (University of Alabama) and as a joint chief investigator  Dr. Hussain has also submitted an application to NIH (USA) for a randomised phase II trial comparing Gemcitabine and Carboplatin with Gemcitabine and split dose cisplatin for patients ineligible for standard cisplatin treatment. This study will be coordinated through the LCTU.

In collaboration with MRC  CDSS Dr. Christopher Goldring and Dr. Ian Copple Dr. Hussain is investigating  pharmacological Inhibition of Nrf2 as a Novel Strategy for Overcoming Cisplatin Drug Resistance in Bladder Cancer

Phase I trials:  

Dr Hussain is chief investigator for UK for a phase I study of panobinostat (HDAC inhibitor) in patients with advanced solid tumours with varying degree of renal functions (Novartis).

He is also setting up a phase I study of CD40-targeted therapy using AdISF35 (Memgen Inc) in patients with BCG-refractory superficial bladder cancer, which is commonly CD40-expressing and may be amenable to immunotherapy.