Evaluating 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.

Not Applicable

Completed

• Conditions: ocally advanced/poor prognosis or metastatic cancer; Cancer

• Registration Number: ISRCTN13913966
• Lead Sponsor: niversity of Leeds

Brief Summary

2019 abstract in https://doi.org/10.1093/annonc/mdz253.039 (added 26/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-26
• Study Completion: 2019-07-31
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified