Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. (1716-12)
HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5.
Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant pleural mesothelioma forms plaques that are distributed on the surface of the pleural space in the lung. Approximately 30% of patients require an indwelling pleural catheter for drainage of pleural effusions. In this patient group, the indwelling catheter may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.
This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.
|Malignant Pleural Mesothelioma||Biological: HSV1716 Intra-pleural delivery||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I/IIa Study of the Safety, Tolerability and Biological Effect of Single and Repeat Administration of the Selectively Replication-competent Herpes Simplex Virus HSV1716 Into the Tumor-bearing Pleural Cavity (Intrapleural) in Patients With Inoperable Malignant Pleural Mesothelioma.|
- Safety and tolerability of HSV1716 given by single and repeat intrapleural administration in patients with inoperable malignant pleural mesothelioma. [ Time Frame: Dose limiting toxicities will be assessed at 28 days after last injection of HSV1716. ]
- Obtain evidence of HSV1716 replication and lysis of malignant pleural mesothelioma cells through analysis of pleural fluid and serum samples for evidence of cell death and/or HSV1716 replication and/or changes in appropriate biomarkers. [ Time Frame: Samples will be collected at each outpatient visit up to day 29 (Part A), or day 50 (Part B). ]
- Tumour measurement as recorded by CT scans and assessed using the modified Response Criteria in Solid Tumors (RECIST) for MPM. [ Time Frame: CT scans at Baseline, day 29 and day 57. ]
|Study Start Date:||October 2012|
|Study Completion Date:||November 14, 2016|
|Primary Completion Date:||November 14, 2016 (Final data collection date for primary outcome measure)|
Single Arm Phase I/II study of intra-pleural HSV1716 administration.
Biological: HSV1716 Intra-pleural delivery
Other Name: Seprehvir
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721018
|Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorkshire, United Kingdom, S10 2SJ|
|Queen Elizabeth Univeristy Hospital, NHS Greater Glasgow & Clyde Health Board|
|Glasgow, United Kingdom, G51 4TF|
|Principal Investigator:||Penella J Woll, MB BS PhD FRCP||Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital, Sheffield, S10 2SJ, UK|