ANZCTR search results

Epstein-Barr virus (EBV) is associated with a number of human malignancies including nasopharyngeal carcinoma (NPC). 100% of undifferentiated NPC tumours are EBV- positive meaning the virus is localised to the tumour cells. We are attempting to develop immunotherapy as an alternate treatment for nasopharyngeal carcinoma (NPC) in addition to radiotherapy, chemotherapy and surgery. This immunotherapy would be in the form of adoptive transfer. This requires that a certain type of white blood cell found in the body known as “killer T-cells” or technically "cytotoxic T lymphocytes" (CTL) be isolated from the NPC patient’s own blood. These T cells are trained in the laboratory to become more efficient at recognising and destroying EBV infected tumour cells. Adoptive transfer is when the EBV-specific T cells are given back to the patient via intravenous infusions. This phase I adoptive immunotherapy trial aims to determine the safety, tolerability and efficacy of adoptive transfer of EBV specific T cells for NPC. The study will be carried out in collaboration with The University of Hong Kong, The Queensland Institute of Medical Research (QIMR) and The Princess Alexandra Hospital, Brisbane. A total of 50 eligible participants will be enrolled on the trial (35 from Hong Kong and 15 from the Princess Alexandra Hospital). Following informed consent, a 200-400ml blood sample will be collected from each participant and transported to the Q-Gen laboratory at QIMR in Brisbane where laboratory staff will begin to grow the T cells with a recombinant adenovirus. This process will take about 15 days. The recombinant adenovirus expresses small fragments from NPC-associated viral proteins this technique is used to stimulate the killer T cells in the laboratory. This adenovirus has been modified in such a way that it is non-infectious and does not cause any disease. This stimulation should result in the T cells being able to recognize EBV proteins on the NPC tumour that are there because of the EBV in the tumour. After recognising these proteins, the T cells will try to kill the tumour. After the killer T cells have been grown they will be purified and all residual adenovirus removed. They will be tested for safety, sterility and specific activity before being transported back to the treating hospital. The participants will undergo several baseline assessments, including blood tests. The killer T cells will be given back to the participant via adoptive transfer. Infusions of between 20-40 x 10^6 CTL will be given intravenously on a fortnightly basis, for up to six infusions. Participants will be monitored once a fortnight for the first 12 weeks and then once a month for four months. Monitoring will involve a series of blood tests and MRI scans. Participants will be on the trial for a total of 33 weeks.

This is the first human study of a novel swine flu vaccine that is designed to identify the optimum dose of vaccine, the optimum number of doses and whether or not an adjuvant is required to provide maximal protection against swine flu

This study looks at treatment with a targeted biological therapy (Epidermal Growth Factor Receptor [EGFR] Targeted, Paclitaxel Loaded EnGeneIC Delivery Vehicles [ErbituxEDVsPac]) in people with advanced epithelial cancer. Who is it for? You can join this study if you have: – advanced epithelial cancer which has spread to secondary or distant sites or cannot be removed by surgery – a tumour type known to express EGFR. Trial details All participants will receive ErbituxEDVsPac Dose at increasing doses. The study will monitor the safety and effectiveness of treatment, in particular the immune and inflammatory response (measured after each treatment) and the tumour response (measured after each six week cycle of treatment).

This study aims to better investigate the underlying problem behind the swallowing difficulties (dysphagia) experienced by many people diagnosed with inflammatory muscle disorders (Inclusion Body Myositis, Dermatomyositis and Polymyositis)

The aim of this study is to determine how adrenaline and clonidine affect the absorption of levobupivacaine in children having caudal anaesthesia for sub-umbilical surgery. Our study hypothesis is that the absorption of levobupivacaine will be affected when administered in conjunction with adrenaline and clonidine via the caudal route.

Increase the influence of fathers on infant feeding practices including initiation and duration of breastfeeding

There are two previous studies (Lynton, Kligler and Shiflett, 2007; Bastille and Gill-Body, 2004), which suggest yoga-based activity programs may be of benefit for stroke survivors but these studies have had quite small sample sizes and have not involved randomized control procedures, which prevent any firm conclusions. A sub study of the North East Melbourne Stroke Incidence Study (NEMESIS) has indicated that interventions which target physical impairment and mood have the potential to improve health-related quality of life in stroke survivors (Sturm et al, 2008). A yoga-based intervention may be able to provide benefits in terms of functional recovery and mood improvement due to its unique combination of exercise-like movements and meditation practices. Participation in yoga programs may be a cost effective, low side effect risk, option for addressing both physical and emotional disabilities in stroke survivors.

This study compares the effectiveness of pre-operative treatment with cisplatin, 5 fluorouracil and docetaxel with or without radiotherapy in treating people who have shown a poor early response to standard chemotherapy for adenocarcinoma of the oesophagus and/or gastroesophageal junction. Who is it for? You can join this study if you have localised adenocarcinoma of the oesophagus or gastroesophageal junction which is due to be treated by surgery. Trial details: After the first cycle of standard cisplatin/5-FU chemotherapy all patients will have a PET scan. Patients who have a poor response on the PET scan, will be randomly divided into two groups. One group will receive chemotherapy (cisplatin/5-FU with the addition of docetaxel) followed by surgery, and the other will receive chemotherapy (cisplatin/5-FU with the addition of docetaxel) and radiation followed by surgery. In both groups, the chemotherapy is given intravenously. In the group receiving radiation treatment, this will overlap with the chemotherapy treatment. The study aims to evaluate the response to the different therapy regimens, by comparing pathology samples, looking at the response on PET scans, toxicity, survival rates and quality of life.

This study aims to investigate the effectiveness of chiropractic treatment for the lower limb kinetic chian. We hypothesize the wider scope of treatment will provide better outcome in pain scores, overall effectiveness, range and motion and gait ability due to the inter-relationahip of the biomechanical change and addressing compensatory actions. We hope it will provide evidence to be included in guidelines for management of osteoarthritis and may provide alternative options to analgesics and surgery.