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. (1716-12)

NCT01721018 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	Virttu Biologics Limited
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	12
Start date	2012-10
Completion	2016-11-14

Conditions

• Malignant Pleural Mesothelioma

Interventions

• HSV1716 Intra-pleural delivery

Primary outcomes

• 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.

Countries

United Kingdom