A Trial of Intra-pleuraL bacterial immuno-Therapy in mesothelioma (TILT): A feasibility study using the ‘trial within a cohort’ methodology

orth Bristol NHS Trust Research & Innovation Department0 个研究点目标入组 12 人开始时间: 2017年12月5日最近更新: 2022年10月17日

适应症

试验速览

•1. Histological or cytological diagnosis of MPM
•2. Enrolled in ASSESS-meso cohort study and has given consent to undergo randomisation for future trials
•3. IPC in situ that has drained more than 50ml of fluid on previous 3 drainages OR willing to have an IPC and has a pleural effusion suitable for IPC insertion
•4. No chemotherapy in preceding 4 weeks and none planned in subsequent 4 weeks
•5. Performance status =2, or PS 3 and felt clinically suitable for trial
•6. Predicted survival =12 weeks from enrolment
•7. Able to give written informed consent & meet trial requirements

•1. No indwelling pleural catheter (IPC) in situ, and has contra-indication to IPC insertion
•2. Clinico-radiological diagnosis of mesothelioma
•3. Trapped lung with < 50% pleural apposition on x-ray
•4. Moderately heavy or heavily loculated pleural effusion
•5. Known immunodeficiency or immuno-suppressive medication
•6. Intercurrent infection (pleural or elsewhere) or clinical signs of sepsis
•7. Known sensitivity or allergy to OK432 or penicillin
•8. Previous treatment with immunotherapy
•9. Currently enrolled in any other interventional clinical trial
•10. Brain metastases or CNS involvement of mesothelioma
•11. Pregnancy or lactation, current or planned during the study period
•12. Age < 18
•13. Any other factor that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated

发起方

orth Bristol NHS Trust Research & Innovation Department