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.
| ISRCTN | ISRCTN13913966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13913966 |
| EudraCT/CTIS number | 2012-000704-15 |
| Secondary identifying numbers | 19097 |
- Submission date
- 26/08/2015
- Registration date
- 26/08/2015
- Last edited
- 26/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
This is 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.
Who can participate?
Adults aged 18 and older who have due to have surgery for metastatic cancer.
What does the study involve?
Pre-operative intravenous administration of JX-594.
What are the possible benefits and risks of participating?
Not provided at the time of registration.
Where is the study run from?
St. James's University Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2015 to July 2019
Who is funding the study?
Transgene (UK)
Who is the main contact?
Mrs Jenny Boards
Contact information
Scientific
St. James's University Hospital
Clinical Sciences Building
Level 6
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 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. |
| Study hypothesis | 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. |
| Ethics approval(s) | GTAC190; First MREC approval date 31/08/2012 |
| Condition | Locally advanced/poor prognosis or metastatic cancer |
| Intervention | Pre-operative intravenous administration of JX-594 |
| Intervention type | Other |
| Primary outcome measure | To assess tissue and blood presence of JX-594 |
| Secondary outcome measures | N/A |
| Overall study start date | 10/08/2015 |
| Overall study end date | 31/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 10/08/2015 |
| Recruitment end date | 31/07/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 6
Beckett Street
Leeds, West Yorkshire
LS9 7TF
United Kingdom
Sponsor information
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/10/2019 | 26/05/2021 | No | No |
Editorial Notes
26/05/2021: Publication reference added.
03/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer, Bladder Cancer, Renal Cancer, Melanoma; Disease: Bladder (advanced), Kidney, Liver, Melanoma" to "Locally advanced/poor prognosis or metastatic cancer" following a request from the NIHR.
15/01/2018: The Plain English summary has been added.
16/10/2017: Internal review.
15/09/2017: Internal review.
06/06/2017: Internal review.
