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Malignant Mesothelioma

Single Arm Phase I/II study of intra-pleural HSV1716 administration.

HSV1716 Intra-pleural delivery

Penella J Woll, MB BS PhD FRCP

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.

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.

Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.

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.

Virttu Biologics Limited

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.	NCT01721018	Malignant Pleur...	HSV1716 Intra-p...	18 Years -	Virttu Biologics Limited
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.	NCT01721018	Malignant Pleur...	HSV1716 Intra-p...	18 Years -	Virttu Biologics Limited

Spots Global Cancer Trial Database for sheffield

Every month we try and update this database with for sheffield cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sheffield

Every month we try and update this database with for sheffield cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sheffield cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.