Malignant pleural mesothelioma G47delta trial

JRCT ID: jRCTs033180326

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant pleural mesothelioma
• Date of first enrollment: 18/03/2019
• Target sample size: 6
• Study type: Interventional
• Intervention(s): A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered into the pleural cavity of patients with inoperable, recurrent or progressive malignant pleural mesothelioma. A fixed dose of G47delta will be administered into the pleural cavity every 4 weeks, maximum 6 times.

Outcome(s)

Primary Outcome

Safety
-Spectrum and frequency of adverse events

Secondary Outcome

Efficacy
-Change in tumor size on CT scan
-Progression free survival
-Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients are eligible to be included in the study only if all of the following criteria apply.
-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

Exclude criteria

Patients are excluded from the study if any of the following criteria apply.
-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

Related Information

• Primary Sponsor: Tanaka Minoru
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000034063