TILT - a trial of a bacterial agent called OK432, administered directly into the chest via an indwelling catheter in people with cancer of the lung lining (mesothelioma).

Phase 1

• Conditions: Malignant pleural mesothelioma; MedDRA version: 20.0Level: PTClassification code 10059518Term: Pleural mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-004727-23-GB
• Lead Sponsor: orth Bristol NHS Trust Research & Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-18
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

To participate in TILT patients must meet all of the following inclusion criteria:
•Histological or cytological diagnosis of mesothelioma
•Enrolled in ASSESS-meso and has given consent to be considered for and be randomly selected for future trials
•Indwelling pleural catheter (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
•No chemotherapy in preceding 4 weeks and none planned in subsequent 4 weeks
•Performance status =2, or PS 3 and felt clinically suitable for trial
•Predicted survival =12 weeks from enrolment
•Able to give written informed consent & meet trial requirements

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

To be eligible for TILT, participants must have none of the following exclusion criteria:
•No indwelling pleural catheter (IPC) in situ, and has contra-indication to IPC insertion
•Clinico-radiological diagnosis of mesothelioma
•Trapped lung with <50% pleural apposition on x-ray
•Moderately heavy or heavily loculated pleural effusion
•Known immunodeficiency or immuno-suppressive medication
•Intercurrent infection (pleural or elsewhere) or clinical signs of sepsis
•Known sensitivity or allergy to OK432 or penicillin
•Previous treatment with immunotherapy
•Currently enrolled in any other interventional clinical trial
•Brain metastases or CNS involvement of mesothelioma
•Pregnancy or lactation, current or planned during the study period
•Age <18
•Any other factor that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified