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

NCT02017678 | Withdrawn Phase 2 DMC

• 1 other identifier: OZM-044
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ovarian Cancer

Keywords

JX-594; Ovarian cancer; Peritoneal; Carcinomatosis; Vaccinia virus; Oncolytic virus

Outcome Measures

Primary Outcomes (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

  6 weeks

Secondary Outcomes (7)

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

  Weekly

• Response rate using modified immune criteria

  6 weeks

• Delivery of JX-594 in solid tumours

  Weekly

• JX-594 Secondary Replication in blood over time

  Weekly

• Immune response to JX-594

  6 weeks

Study Arms (1)

JX-594 IV Infusion

EXPERIMENTAL

Patients with peritoneal carcinomatosis of ovarian origin that are not eligible for curative treatments will receive 5 weekly IV infusions of JX-594

Biological: JX-594

Interventions

JX-594 BIOLOGICAL

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

Also known as: vaccinia virus

JX-594 IV Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Andrea McCart: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma; Vaccinia

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Judith Andrea McCart, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Helen MacKay, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastrointestinal Surgical Oncologist

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

CA (1)