Phase 1 clinical trial of an intrathoracic administration of adenoviruses harboring the NK4 gene (AdCMV-NK4) for subjects with unresectable malignant pleural mesothelioma - Gene therapy with NK4-expressing adenoviruses for malignant pleural mesothelioma

Graduate School of Medicine, Chiba University0 sites9 target enrollmentJanuary 1, 2015

Overview

No summary available.

Registry

who.int

Start Date

January 1, 2015

End Date

December 31, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Graduate School of Medicine, Chiba University

•Patients with active or uncontrolled infectious diseases and /or the severe complications Patients who have another malignancy besides malignant mesothelioma, synchronous or metachronous. Patients who have achieved complete cure or have progression free interval longer than 2 years are acceptable Patients who have symptomatic brain metastatic foci and / or require a treatment for it Patients who do not have enough intra\-thoracic room for viral injection Patients who have participated in other clinical trial with approved or unapproved medicine within 4 weeks before the entry in this study Patients who are scheduled to receive another anticancer drug during the study period Patients who have already treated with pleurodesis for mesothelioma Patients who have peripheral nerve palsy more than grade 2 in CTCAE vers 4\.0 at the entry Patients who have apparent interstitial diseases and pulmonary fibrosis on chest X ray Patients who have any problems including mental, familial, social or geographic issues that prevent good compliance to achieve this study Patients who have already undergone a treatment using adenoviral vectors Patients who have a treatment history of auto or allograft organ transplantation Patients who are positive for HIV antigen, HBV antigen, HCV antibody, and HTLV 1 antibody Patients who are judged as inappropriate to participate this study by the principal investigator and the collaborators