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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
5 weekly IV infusions of JX-594 followed by laparoscopy and biopsy on day 10 or 38.
Princess Margaret Cancer Center
Toronto, Ontario, Canada
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
Time frame: 6 weeks
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
Time frame: Weekly
Response rate using modified immune criteria
Determine response rate using modified immune criteria in ovarian peritoneal carcinomatosis
Time frame: 6 weeks
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
Time frame: Weekly
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.
Time frame: Weekly
Immune response to JX-594
Determine the immune response to JX-594 by change in peripheral white blood cell counts over time
Time frame: 6 weeks
Response of tumour markers to JX-594
Determine serum tumor marker response rate
Time frame: Weekly
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Time to progressive disease
Determine time to progression of disease after JX-594 administration
Time frame: 6 weeks