We are currently conducting clinical researches with 2 agents in Department of Respirology, Graduate School of Medicine, Chiba University, Japan.
Patients eligible for the studies are those who are pathologically diagnosed as malignant pleural mesothelioma of locally advanced or recurrent cases, and not suitable for surgical resection.
(1) Adenoviruses expressing NK4 gene (Ad-NK4)
The agent is a gene medicine, using non-toxic adenoviruses as a gene-transferring vector, to express NK4 protein in tumors and tissues closed to the tumors, and consequently inhibits the tumor growth and nutritional channels to the tumors. The study design is to administer saline solution containing Ad-NK4 into the pleural cavity of mesothelioma patients, and includes a dose escalation schedule with 3 patients at respective doses of Ad-NK4. The purpose is to know a safety level of an intrapleural injection of Ad-NK4 and a maximum tolerance dose of the agent. The study was approved by the Ministry of Health, Labor and Welfare of Japan (KAHATSU 0822-1), and was registered at UMIN clinical trials registry, Japan (UMIN15771).
(2) Zoledronic acid
This is a Phase I study to test a safety level of an intrapleural injection and a maximum tolerance dose of the agent. The agent is currently used through an intravenous route for patients of osteoporosis or malignancy-induced hypercalcemia in a clinical setting. We found that the agent produced cytotoxic effects to mesothelioma by inhibiting a number of small G protein functions. The clinical protocol was approved by the institutional review board of the Chiba University Hospital (G23070) and that of Graduate School of Medicine, Chiba University (TIBADAI-IN No: 205), and was registered at UMIN clinical trials registry, Japan (UMIN 8093).
The above studies are not a clinical study by any of pharmaceutical companies but a doctor-initiated research. Those who are interested in the study can access further information at a website http://www.m.chiba-u.ac.jp/class/respir/clinical_trial/mesothelioma/index.html
References about the protocol