Locally advanced/poor prognosis or metastatic cancer Cancer
Conditions
Interventions
Pre-operative intravenous administration of JX-594
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 6. Karnofsky Performance Score (KPS) = 70 7. Haemoglobin = 9 g/dL (correction with transfusion allowed) 8. Platelets = 100 x 109 (without platelet transfusion) 9. Absolute neutrophil count (ANC) = 1.5 x 109 10. Total bilirubin = 1.5 upper limit of normal (ULN) 11. AST or ALT = 2.5 ULN 12. INR = 1.7 13. Serum creatinine = 1.5 x ULN 14. For patients who are sexually active, able and willing to abstain from sex for 3 weeks following treatment. Willing to use barrier method to protect partner against infection for up to 6 weeks after the JX594 treatment 15. Negative pregnancy test within 7 days of treatment if female and premenopausal 16. Willing and able to provide informed consent 17. Willing and able to comply with scheduled visits, the treatment plan and laboratory tests
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess tissue and blood presence of JX-594 | — |
Countries
United Kingdom
Outcome results
None listed