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.
The study will be conducted in two parts. PART A is a single centre, single dose design,
open label. Patients with inoperable malignant pleural mesothelioma will receive a single
dose of HSV1716 by intrapleural administration. Delivery will be by direct administration
via an indwelling catheter into the pleural cavity. PART B is a single centre, repeat dose
design, open label. Two groups of three patients with inoperable malignant pleural
mesothelioma will receive 2 (group 1) or 4 (group 2) single doses of HSV1716 at weekly
intervals. Administration will be via an indwelling catheter into the pleural cavity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of HSV1716 given by single and repeat intrapleural administration in patients with inoperable malignant pleural mesothelioma.
Dose limiting toxicities will be assessed at 28 days after last injection of HSV1716.
Penella J Woll, MB BS PhD FRCP
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital, Sheffield, S10 2SJ, UK
United Kingdom: Medicines and Healthcare Products Regulatory Agency