Condition category
Cancer
Date applied
26/08/2015
Date assigned
26/08/2015
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jenny Boards

ORCID ID

Contact details

St. James's University Hospital
Clinical Sciences Building
Level 6
Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

2012-000704-15

ClinicalTrials.gov number

Protocol/serial number

19097

Study information

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.

Acronym

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

GTAC190; First MREC approval date 31/08/2012

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer, Bladder Cancer, Renal Cancer, Melanoma; Disease: Bladder (advanced), Kidney, Liver, Melanoma

Intervention

Pre-operative intravenous administration of JX-594

Intervention type

Other

Phase

Drug names

Primary outcome measures

To assess tissue and blood presence of JX-594

Secondary outcome measures

N/A

Overall trial start date

10/08/2015

Overall trial end date

31/07/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

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

United Kingdom

Trial participating centre

St. James's University Hospital
Clinical Sciences Building Level 6 Beckett Street
Leeds, West Yorkshire
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Transgene

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.