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Clinical Trials/ISRCTN13913966
ISRCTN13913966Completed未知

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 enrollmentStarted: August 26, 2015Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
niversity of Leeds

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