Malignant pleural mesothelioma
Conditions
Interventions
This clinical study is an open-label, single-armed, phase I study. A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered into the pleural cavity of patients
Sponsors
IMSUT Hospital, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed malignant pleural mesothelioma that is inoperable, recurrent or progressive. -No prior thoracotomy or thoracoscopic surgery, except for biopsy. -History of chemotherapy or radiotherapy is irrelative. -Presence of one or more evaluable lesions on contrast-enhanced CT scan within 14 days of G47delta administration -Interval of 4 weeks or more from prior chemotherapy - Performance Scale (PS) = 0 to 1 -Age >= 20 years -Willing to use effective barrier birth control for at least 6 months after G47delta administration -Expected survival >= 3 months -Sufficient major organ functions -Laboratory test results meet the following criteria A) White blood cell count>2000/mm3, Absolute neutrophil count (ANC)>1000 /mm3, Platelets>60000 /mm3, Hemoglobin>9.0 g/dL B) Prothrombin time-international normalized ratio <= 1.3 times the upper limit of facility reference value C) Serum creatinine<1.7mg/dL D) AST and ALT <= 4 times the upper limit of facility reference value E) Total bilirubin<=1.5 mg/dL
Exclusion criteria
Exclusion criteria: -Known HIV seropositivity -Any contraindication for undergoing iodine contrast enhanced CT scan -Insufficient space in the pleural cavity to inject G47delta -Evidence of active herpes infection or requires antiviral therapy for HSV -Active and uncontrolled infection -History of myocardial infarction within 3 months -Uncontrolled or severe medical condition such as heart failure, angina pectoris, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, and autoimmune disease -History of alcohol or other drug dependency. - Active double cancer -Allergy to anti-HSV drug -Administration of other clinical study drugs or research treatments within 30 days of G47delta administration -Prior gene therapy or oncolytic virus therapy other than G47delta -Pregnant or nursing females -Conditions considered inadequate for the subject to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety -Spectrum and frequency of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Change in tumor size on CT scan -Progression free survival -Overall survival | — |
Countries
Japan
Contacts
Public ContactFumitaka Nagamura
IMSUT Hospital, The University of Tokyo Center for Translational Research
Outcome results
None listed