Chemotheapy-resistant Malignant Pleural Mesothelioma
Conditions
Sponsors
Osaka University Hospital, Center for respiratory
GenomIdea,Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients providing a written informed consent by voluntary agreement. 2) Age 20 =< and =<85 years old at the time of informed consent 3) Have a diagnosis of malignant pleural mesothelioma as confirmed by histology 4) Patinets suffering from chemoresistant malignant pleural mesothelioma, or patients without consecutive chemotherapy. - More than 6 week between the end date of the Chemotherapy and the registration date when the Chemotherapy has been ineffective 5) PaO2 >=70 mmHg and SpO2>=93% 6) Expected survival period is more than 8 weeks after planned start date of investigational product 7) ECOG Performance Status 0 or 1 8) Patients with lesions which can be detected by diagnostic imaging such as MRI or CT scan prior to treatment, and which can be administered with GEN0101/HVJE 9) The marrow function, liver function and the kidney function must be kept as follows at the screening visit (1) leukocyte >= 3,000/mcL (2) neutrophil >=1,500/mcL (3) platelet >=75,000/mcL (4) hemoglobin >=8.0 g/dL. (5) AST =<100 IU/L (6) ALT =<100 IU/L (7) total bilirubin =<2.5 mg/dL (8) serum creatinine =<2.5 mg/dL
Exclusion criteria
Exclusion criteria: 1) Have multiple brain metastases 2) Positive result of the prick test of GEN0101 3) Have serious complications such as uncontrolled active infection 4) Received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before planned registration date 5) Received another investigational product within 4 weeks before the informed concent 6) Had a history of othr malignancy, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration 7) Have a interstitial pneumonia or fibrosing disease of the lung that need treatment 8) Have an active autoimmune disease 9)Receiving systemic administration of glucocorticosteroid which restrains immunity response. 10) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication) 11) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit 12) Pregnant or lactating women, except for the woman who discontinue to lactate (from the day of a written informed consent to the day after 30days of discontinue the administration) In the case of womane, to conduct beta-HCG tests to confirm the presenceor absence of pregnancy 13) Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit 14) Inappropriate to be enrolled in this study judged by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of DLT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Effect of tumor shirinkage - RECIST - Tumor marker (SMRP, CYFRA) 2)Induction of antitumor immunity - NK cell - IL-6 - IFN-gammma 3)Blood concentration of GEN0101/HVJ-E | — |
Countries
Japan
Contacts
Public ContactKatsuhisa Saito
Osaka University Hospital Medical Center for Translational and Clinical Research
Outcome results
None listed