A clinical study to evaluate the biological effects of pre-operative intravenous administration of JX-594 (thymidine kinase-deactivated Vaccinia virus plus GM-CSF) prior to planned surgical resection of locally advanced/poor prognosis or metastatic cancers.

niversity of Leeds0 sites40 target enrollmentAugust 26, 2015

Overview

Registry

who.int

Start Date

August 26, 2015

End Date

July 31, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds

•1\. Patients with histologically proven or radiological findings consistent with locally advanced/poor prognosis or metastatic cancer, planned for surgical resection (curative or palliative) of primary or metastatic disease as part of standard clinical care. Patients with the following diseases will be eligible:
•1\.1\. Metastatic melanoma due for lymph node dissection for lymph node macrometastases (Stage IIIB/C) or
•metastasectomy at any other site
•1\.2\. Muscleinvasive transitional cell bladder cancer due for partial or total cystectomy
•1\.3\. Primary hepatocellular carcinoma due for liver resection
•1\.4\. Locally advanced/metastatic renal cell cancer planned for palliative nephrectomy
•2\. Willing to have full preoperative workup prior to planned resection consistent with standard clinical practice appropriate for disease site and intervention planned
•3\. Fit for the planned surgical intervention
•4\. Life expectancy of at least 3 months
•5\. At least 18 years of age

•1\. Pregnant or nursing an infant
•2\. Patients on immunotherapy or known HIV infection or hepatitis B or C
•3\. Clinically significant active infection or uncontrolled medical condition (e.g. pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary), such that unfit for surgery or interfering with interpretation of trial
•4\. Severe or unstable cardiac disease, including significant coronary artery disease requiring angioplasty or stenting within the preceding 12 months, unless wellcontrolled on stable medical therapy for at least 3 months
•5\. Known CNS malignancy (history of brain metastases completely resected or treated by gamma knife therapy or whole brain radiotherapy)
•6\. Clinically significant and reaccumulating ascites, pericardial and/or pleural effusions
•7\. Tumour(s) in a location that would potentially result in significant clinical adverse effects if posttreatment tumour swelling were to occur (e.g. tumours causing near total blockage of the common bile duct)
•8\. Anticancer therapy (e.g. chemotherapy, surgery, radiotherapy, investigational agent) within 4 weeks prior to treatment with JX594
•9\. History of a severe systemic reaction or sideeffect as a result of a previous smallpox vaccination
•10\. History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy