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Colorectal CarcinomaPhase 2NCT01329809

Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection

A Phase 2 study testing Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) in people with Colorectal Carcinoma, run by Jennerex Biotherapeutics at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteCanada
Study dates
Oct 2011to Mar 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The planned surgical resection must be margin negative with complete resection or resection plus radiofrequency ablation (RFA) of metastatic CRC as determined by principal investigator or surgeon
  • Diagnosis of histologically-confirmed metastatic colorectal tumor(s) within the liver eligible for surgical resection. Eligible patients must have: preoperative work-up that reveals potential resectability (CT scan or MRI of the abdomen and pelvis and CT scan of the chest within 6 weeks of enrollment) preoperative work-up to ensure operability with general medical clearance as indicated
  • At least one measurable tumor mass by MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter ≥ 1 cm)
  • Plan for a maximum resection of six (6) liver segments
  • Child Pugh A (Refer to APPENDIX C: Child-Pugh Classification
  • Performance Score: KPS score of ≥ 70
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  • Age ≥18 years
  • For patients treated with IT injection only: at least 1 intra-hepatic tumor with longest diameter (LD) ≥ 1.5 cm and ≤ 12 cm and which is technically amenable to injection under radiographic guidance targeted for surgical resection.
  • In patients treated with IT injection, the injected tumor must be included in the surgical resection specimen (a planned RFA of the injected tumor would not be eligible)
  • Total bilirubin ≤ 3 x ULN
  • AST, ALT < 5.0 x ULN
  • WBC ≥ 3.5x 109/L and ≤ 50 x 109/L
  • ANC ≥1.5 x 109/L
  • CD4 ≥ 200 total cells/mm3
  • Hemoglobin ≥ 80g/L
  • Platelet count ≥ 100 x 109/L
  • Acceptable coagulation status: INR ≤ 1.4
  • Creatinine ≤ 2 x ULN
  • Serum Sodium, Potassium and Calcium levels ≤ Grade 1
  • If patients are diabetic or have a screening random glucose > 8.9mmol/L, a fasting glucose must be done and results must be WNL or Grade 1 in order to be eligible for the study.
  • For patients who are sexually active: patient must be able and willing to abstain from sex during JX-594 treatment period (to prevent pregnancy) and willing to use barrier method for at least 6 weeks after the last JX-594 treatment (to protect partner against infection).
  • Able and willing to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB)-approved written consent form Able and willing to comply with study procedures and follow-up examinations, including compliance with the "Infection Control Guidelines for Patients" contained within the written consent form.

Who cannot join

  • Prior local-regional treatment (including hepatic arterial infusion, hepatic embolization, radiofrequency ablation) for tumor downstaging. Prior adjuvant chemotherapy will be accepted as long as the duration between chemotherapy and the development of metastases has been >8 weeks.
  • Pregnant or nursing an infant
  • Known myeloproliferative disorders requiring systemic therapy
  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. high dose systemic corticosteroids taken for more than 4 weeks within the preceding 3 months)
  • History of severe exfoliative skin condition (e.g. eczema or atopic dermatitis requiring systemic therapy for more than 4 weeks)
  • Tumor(s) invading a major vascular structure (e.g. carotid artery)
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  • Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
  • Clinically significant active infection, requiring systemic antibiotic therapy, or uncontrolled medical condition which would, in the opinion of the principle investigator, impair the ability of the subject to receive protocol therapy
  • Severe or unstable cardiac disease, including significant coronary artery disease requiring angioplasty or stenting within the preceding 12 months, unless well-controlled and on stable medical therapy for at least 3 months
  • Known viable CNS malignancy (history of completely resected or irradiated brain metastases allowed)
  • Chronic use of anti-platelet or anti-coagulation medication that cannot be temporarily discontinued for at least seven days prior to treatment with JX-594. (Note: the following are allowed: low dose aspirin ≤ 100 mg, low dose coumadin as long as INR ≤ 1.4 and low-dose heparin to maintain port access)
  • Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (at least 7 days prior to the first treatment), and PEG-IFN (at least 14 days prior to the first treatment).
  • Absolute contraindication to undergoing MRI scanning (e.g. pacemaker, paramagnetic intracranial aneurysm clip, inner ear implants, fragments of metal within the body, etc.).
  • Pulse oximetry O2 saturation < 90% at rest
  • Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
  • Inability or unwillingness to give informed consent or comply with the procedures required in this protocol.
  • Patients with household contacts who meet any of these criteria will be excluded unless alternate living arrangements can be made during the patient's dosing period and for at least 7 days following the last dose of study medication
  • Pregnant or nursing an infant
  • Children < 1 year old
  • People with skin disease (eczema, atopic dermatitis and related diseases
  • Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologist malignancies)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ottawa Hospital and Research Institute (OHRI)

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Phase IIa Study of Neoadjuvant JX-594 Administered by Intravenous Infusion or Intratumoral Injection Followed by Surgical Resection in Patients With Metastatic Colorectal Tumors Within the Liver

This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver.

Read the detailed description

Patients will receive either an intravenous infusion or an intratumoral injection of JX-594 (Pexa-Vec) directly into one liver lesions at Day 1. Patients will undergo a complete resection of all liver tumors at Day 15. Patients will then be monitored throughout their life for disease recurrence and/or general overall survival.

Being tested
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Keywords
metastatic colorectal cancer, colon cancer, liver metastasis, Pexa-vec, JX-594
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)Drug

    Also called JX-594

    intratumoral or intravenous dosage: 10e9 pfu Intravenous: administered over 60 minutes Intratumoral: direct injection into a single liver lesion

Study groups in NCT01329809
Study groupRoleWhat they receive
JX-594 Intravenous infusionExperimentalAt Day 1 patients will receive either an intratumoral injection or intravenous infusion. The treatment given is determined by the patient's tumor characteristics. Patients with ≥ 2 qualifying intrahepatic CRC metastases, where at least one (1) tumor measures ≥ 1.5 cm LD and is injectable under radiographic guidance (e.g. ultrasound or CT guidance), will receive an intratumoral injection. Patients with only one (1) qualifying intrahepatic CRC metastasis, or with tumors < 1.5cm and/or no injectable tumors, will receive an intravenous infusion.
Receives: Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
JX-594 Intratumoral InjectionExperimentalAt Day 1 patients will receive either an intratumoral injection or intravenous infusion. The treatment given is determined by the patient's tumor characteristics. Patients with ≥ 2 qualifying intrahepatic CRC metastases, where at least one (1) tumor measures ≥ 1.5 cm LD and is injectable under radiographic guidance (e.g. ultrasound or CT guidance), will receive an intratumoral injection. Patients with only one (1) qualifying intrahepatic CRC metastasis, or with tumors < 1.5cm and/or no injectable tumors, will receive an intravenous infusion.
Receives: Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delivery to and Replication Within Tumors

    IT injection: replication and dissemination of JX-594 following injection of a single colorectal metastasis within the liver. A positive replication response is defined as a > 2-fold increase in viral genome concentration in the blood(as measured in the first 12 hours following injection) within the first 14 days following treatment.

    Note: Viral genomes will be measured in the blood by Q-PCR at baseline, on Day 1 (15 minutes, 3 hours \& 8 hours) post-treatment and on Days 3, 5, 8, 11 and 15.

    IV infusion: assessment of viral gene \& protein expression in histologic samples of tumor tissue

    Measured: Day 1, 3, 5, 8, 11, and 15

Secondary outcomes (3)

  1. JX-594 Spread to, and Replication Within, Non-injected Tumors After IT JX-594 Injection

    JX-594 spread to, and replication within, non-injected tumors after IT JX-594 injection as measured by the presence of viral protein expression and/or LacZ expression in non-injected tumor sections from at least 1) two different non-consecutive cuts, both of which contain viable tumor tissue in at least 10 high power fields; and 2) at least 5 cells in one high power field show positive staining for viral protein and/ or LacZ expression

    Measured: Day 1

  2. Modified Choi Response Assessment

    Modified Choi response assessment based on DCE-MRI at baseline and between Days 8 14 (within 7 days prior to surgical resection)

    Measured: Day 8-14

  3. Toxicity: Grade I-IV Adverse Events (According to CTCAE)

    Toxicity: Grade I-IV Adverse Events (according to CTCAE); including surgical complications such as delay of surgery, prolonged hospitalization, bleeding (monitor transfusion requirements), postoperative infections, bile leak, hepatic failure sepsis and death

    Measured: Day 1- Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJan 2012
  4. Study completionMar 2013

Why it stopped: Business decision by the sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329809
Sponsor's protocol ID
JX594-HEP012
Other IDs
BB-IND 6486
Status last verified
Sep 2026
First submitted
4 Apr 2011
Last updated
2 Oct 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) in people with Colorectal Carcinoma, run by Jennerex Biotherapeutics at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delivery to and Replication Within Tumors (time frame: Day 1, 3, 5, 8, 11, and 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01329809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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