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Ovarian CancerPhase 2NCT02017678

Phase 2 Study of JX-594 in Patients With Peritoneal Carcinomatosis of Ovarian Cancer Origin

A Phase 2 study testing JX-594 in people with Ovarian Cancer, run by Andrea McCart at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly IV infusions of JX-594 until radiographically determined progressive disease. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
JX-594
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Jan 2014to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed ovarian carcinomatosis with; no curative treatment options available, or the patient has refused or cannot tolerate the standard therapy. Patients must have had prior primary platinum based chemotherapy.
  • Radiologically evaluable disease.
  • At least 2 tumor masses amenable to biopsy (excisional or core) or laparoscopy. Tumor masses selected cannot be followed by Response Evaluation Criteria in Solid Tumors 1.1.
  • Expected survival ≥12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Women aged ≥18 years
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  • Sexually active patients must be able and willing to abstain for a minimum of 15 days after treatment with JX-594 and subsequently use barrier method for at least 6 weeks after the last JX-594 treatment
  • Signed informed consent form
  • No contraindications to undergo general anesthetic or laparoscopy.
  • Laboratory requirements:
  • Hematology
  • Absolute neutrophil count (ANC) ≥1.0 x 109/L
  • Lymphocytes ≥0.5 x109/L
  • Hemoglobin ≥90 g/L (correction with transfusion or erythropoietin based therapy allowed)
  • Platelet count ≥75 x 109/L
  • Biochemistry
  • Total bilirubin ≤1.5 x upper limit of normal (ULN)
  • Alkaline Phosphatase (ALP), Aspartate transaminase (AST), alanine aminotransferase (ALT) ≤3 x ULN (if patient exhibits liver metastasis, up to 5 x ULN acceptable)
  • Serum creatinine ≤1.5 x ULN or creatinine clearance is ≥1.0 mL/s according to Cockroft-Gault formula
  • International normalized ratio (INR) ≤1.5 Serum chemistries within normal limits (WNL) or Grade 1 (with exception of sodium, potassium, glucose, calcium, phosphate,magnesium, chloride upon Investigator discretion)

Who cannot join

  • Significant immunodeficiency due to underlying illness (e.g., known HIV/AIDS) and/or medication (e.g., systemic corticosteroids taken for more than 4 weeks within the preceding 3 months). Intermittent doses of corticosteroids as an antiemetic for chemotherapy are acceptable. Patients have to be off continuous steroids for at least 4 weeks
  • Therapeutic anticoagulant therapy
  • History of severe exfoliative skin condition (e.g., eczema or ectopic dermatitis requiring systemic therapy for more than 4 weeks)
  • Tumor(s) invading a major vascular structure (e.g., carotid artery)
  • Clinically significant and uncontrolled pericardial or pleural effusions
  • Severe or unstable cardiac disease, including significant coronary artery disease (e.g., requiring angioplasty or stenting) within the preceding 12 months, unless well-controlled and on stable medical therapy for at least 3 months
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  • Tumor burden >50% of abdominal cavity or malignant obstruction of small bowel or other condition that would preclude safe biopsy or laparoscopy
  • Brain metastasis: Viable central nervous system (CNS) malignancy associated with clinical symptoms (Note: enrollment allowed if completely resected or stable post radiotherapy >12 weeks).
  • Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
  • Prior participation in other research protocol involving an investigational product within 4 weeks or 5 half-lives, whichever is longer, prior to first treatment
  • Medical condition, laboratory abnormality or active infection that in the judgment of the Principal Investigator may increase the risk associated with study participation or may prevent laparoscopy or may interfere with interpretation of study results and/or otherwise make the patient inappropriate for study entry
  • Use of interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX-594 dose. (Note: please consult Ozmosis Research Inc. if patient is taking any other anti-viral medications to determine eligibility)
  • Unable to receive IV contrast for CT scanning due to documented history of iodinated contrast allergy unless controlled by medical intervention (e.g., premedication with steroids, diphenhydramine, or other anti-allergic medications)
  • Pregnant or nursing an infant
  • Pulse oximetry O2 saturation <90% at rest on room air
  • Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Center

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Single-arm, Open-label, Phase 2 Study of JX-594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by 5 Weekly Intravenous (IV) Infusions in Patients With Peritoneal Carcinomatosis of Ovarian Cancer Origin

This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly IV infusions of JX-594 until radiographically determined progressive disease. Patients will be allotted in a 1:1 ratio to undergo a laparoscopy and tumor biopsy 10 days after dose 1 or 10 days after Dose 5. Patients will be monitored on study until evidence of progression or death or for 12 months post treatment.

Read the detailed description

This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly IV infusions of JX-594 and will continue to receive IV infusion of JX-594 every 3 weeks until radiographically determined progressive disease. Using a 2 stage trial design, if 2 or more of the first 15 patients show a clinical response as defined by Response Evaluation Criteria in Solid Tumors 1.10 criteria (or if 3 of the 15 have stable disease as defined by Modified Response Evaluation Criteria in Solid Tumors 1.1 or clinically), the arm will be expanded to a total of 25 patients (Stage 2).

In Stage 1, patients will be allotted in a 1:1 ratio to undergo a laparoscopy and tumor biopsy 10 days after dose 1 or 10 days after Dose 5. A decision as to whether laparoscopy will be performed in Stage 2 will be reached at the conclusion of Stage 1.

Patients will be monitored on study until evidence of progression or death or for 12 months post treatment

Conditions
Ovarian Cancer
Being tested
JX-594
Keywords
JX-594, Ovarian cancer, Peritoneal, Carcinomatosis, Vaccinia virus, Oncolytic virus
Medical subject headings
Ovarian Neoplasms, Carcinoma, Vaccinia

What participants receive

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

  • JX-594Biological

    Also called vaccinia virus

    5 weekly IV infusions of JX-594 followed by laparoscopy and biopsy on day 10 or 38.

Study groups in NCT02017678
Study groupRoleWhat they receive
JX-594 IV InfusionExperimentalPatients with peritoneal carcinomatosis of ovarian origin that are not eligible for curative treatments will receive 5 weekly IV infusions of JX-594
Receives: Biological: JX-594

What is being measured

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

  1. Radiographic response of ovarian peritoneal carcinomatosis to JX-594 treatment

    Determine radiographic response rate (response evaluation criteria in solid tumors [modified Response Evaluation Criteria in Solid Tumors 1.1])to JX-595

    Measured: 6 weeks

Secondary outcomes (7)

  1. Assessment of Adverse Events related to JX-594 administered by repetitive IV infusion

    Collection of incidence(s) of treatment-emergent adverse events will be tabulated and stratified by severity and relationship to JX-594 administration

    Measured: Weekly

  2. Response rate using modified immune criteria

    Determine response rate using modified immune criteria in ovarian peritoneal carcinomatosis

    Measured: 6 weeks

  3. Delivery of JX-594 in solid tumours

    Determine the delivery of JX-594 to solid tumors after repetitive IV infusion in patients with peritoneal carcinomatosis

    Measured: Weekly

  4. JX-594 Secondary Replication in blood over time

    Determine the pharmacokinetics of JX-594 by examining secondary replication of viral genomes in blood over time.

    Measured: Weekly

  5. Immune response to JX-594

    Determine the immune response to JX-594 by change in peripheral white blood cell counts over time

    Measured: 6 weeks

  6. Response of tumour markers to JX-594

    Determine serum tumor marker response rate

    Measured: Weekly

  7. Time to progressive disease

    Determine time to progression of disease after JX-594 administration

    Measured: 6 weeks

Timeline

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

  1. First posted23 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2015 (estimated)
  4. Study completionJun 2015 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02017678
Sponsor's protocol ID
OZM-044
Status last verified
Sep 2014
First submitted
20 Sep 2013
Last updated
17 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JX-594 in people with Ovarian Cancer, run by Andrea McCart 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 20 inclusion and 16 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: withdrawn, as of the sponsor's last update on 17 Sep 2014. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Radiographic response of ovarian peritoneal carcinomatosis to JX-594 treatment (time frame: 6 weeks). 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 NCT02017678.

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 17 Sep 2014.

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