A clinical study of adenovirus mediated Reduced Expression in Immortalized Cells/Dickkopf-3 (REIC/Dkk-3) gene therapy for malignant pleural mesothelioma

Phase 1

• Conditions: malignant pleural mesothelioma

• Registration Number: JPRN-UMIN000013568
• Lead Sponsor: Okayama University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with poor-controlled systemic disease 2)Patients with active infections 3)Patients with active double cancer 4)Patients with brain metastasis 5)Patients with interstitial pneumonia or lung fibrosis detected by CXR 6)Patients with recurrent malignant pleural mesothelioma after extrapleural pneumonenctomy or Patients with pneumonectomy due to the disease other than malignant pleural mesothelioma 7)Patients with cardiac effusion requiring the treatment 8)Patients more than 1:1000 titer of neutralizing antibody for adenovirus 9)Patients injected with unapproved drugs within 4 weeks 10) Pregnant or breast-feeding females and females who have a possibility of pregnancy or lactation or patients who does not intend to use birth control 11) Patients who can not use contraception for 90 days after the final administration of REIC 12) Other patients judged to be ineligible by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability: Performance Status CBC (including platelets, fibrinogen, SGPT, lactic dehydrogenase) Adverse events (AEs) Physical examination (PE) Vital signs (VS) Clinical laboratory values

Secondary Outcome Measures

Name	Time	Method
Evaluation of gene therapy Chest CT (1, 2, 4 weeks) lymphocyte analysis (2, 3, 4 weeks)