Phase 1 clinical trial of an intrathoracic administration of adenoviruses harboring the NK4 gene (AdCMV-NK4) for subjects with unresectable malignant pleural mesothelioma
- Conditions
- malignant pleural mesothelioma
- Registration Number
- JPRN-UMIN000015771
- Lead Sponsor
- Graduate School of Medicine, Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of frequency of the adverse events and limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method antitumor effect (response to the treatment)