malignant pleural mesothelioma
Conditions
Interventions
1.0 x 10E11 virus particle
3.0 x 10E11 virus particle
1.0 x 10E12 virus particle
3.0 x 10E12 virus particle
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven malignant pleural mesothelioma 2) Tumor lesions that can be detected by diagnostic imaging 3) Patients should be at least 20 years old and younger than 75 years old 4) ECOG performance status of 0 or 1 5) If radiotherapy was performed before case entry, irradiation should be within 25% of the bone with hematopoietic capacity, and 21 or more days should elapse at case entry since the final irradiation 6) If surgical therapy other than extrapleural pneumonectomy was performed, 21 or more days should elapse at case entry since the day of operation and there should be evaluable lesions 7) Functions of main organs are maintained, satisfying the following conditions Hemoglobin concentration >= 9.0 g/dL White blood cell count >= 3,000/mm3 or Neutrophil count >= 2,000/mm3 Platelet count >= 100,000/mm3 AST and ALT <= 2.5 X of normal values in each institution Total bilirubin <= 1.5 X of normal values in each institution Serum creatinine < 1.5 mg/dL SpO2 >= 92% (room air) ECG: within normal limit 8) Patients expected to be alive for at least 12 weeks since case entry 9) Written consent by patients themselves should be obtained. 10) For chemotherapy, the patients should be either of the following a, b or c. a. Patients refractory to the chemotherapy including pemetrexed, and more than 3 weeks should elapse at case entry since the final administration. b. Patients who can not undergo chemotherapy due to the severe hypersensitivity c. Patients who refuse the systemic chemotherapy for malignant pleural mesothelioma 11) For radical surgery, the patients should be either of the following a or b. a. Patients not indicated for extrapleural pneumonectomy b. Patients who refuse the radical surgery for malignant pleural mesothelioma
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: Performance Status CBC (including platelets, fibrinogen, SGPT, lactic dehydrogenase) Adverse events (AEs) Physical examination (PE) Vital signs (VS) Clinical laboratory values | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of gene therapy Chest CT (1, 2, 4 weeks) lymphocyte analysis (2, 3, 4 weeks) | — |
Countries
Japan
Contacts
Public ContactHiromasa Yamamoto, Yuho Maki
Okayama University Hospital Thoracic Surgery
Outcome results
None listed