A trial of OK-432 administered into the chest cavity via an indwelling pleural catheter in people with mesothelioma

Phase 2

Completed

• Conditions: Specialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs; Cancer; Lung Cancer

• Registration Number: ISRCTN10432197
• Lead Sponsor: orth Bristol NHS Trust Research & Innovation Department

Brief Summary

2020 Thesis results in https://oatd.org/oatd/record?record=handle\:1983\%2Fb791a2a7-118d-4738-a44e-5d294a32c1b6 (added 12/01/2022) 2021 Preprint results in https://doi.org/10.21203/rs.3.rs-256386/v2 (added 17/05/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36057634/ (added 05/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-05
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility is assessed using the following feasibility targets:<br> 1. Recruitment rates to time & target >66%, i.e. 18 participants in 12 month recruitment window, or 24 participants in 18 months. This will be assessed using screening and recruitment logs at 12 months and end of trial.<br> 2. Attrition rate of <20%, assessed from participant withdrawal forms at end of trial (nb this relates solely to attrition due to loss to follow up or participant withdrawal, it does not include attrition due to participant death)<br> 3. Data completeness rates >90% assessed using the trial database at end of trial<br>