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| Name | Class |
|---|---|
| Ontario Institute for Cancer Research | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JX-594 | Biological | 5 weekly IV infusions of JX-594 followed by laparoscopy and biopsy on day 10 or 38. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weekly |
| Response rate using modified immune criteria |
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Inclusion Criteria:
Hematology
Biochemistry
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Andrea McCart, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Helen MacKay, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Center | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002277 | Carcinoma |
| D014615 | Vaccinia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Determine response rate using modified immune criteria in ovarian peritoneal carcinomatosis |
| 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 | 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. | Weekly |
| Immune response to JX-594 | Determine the immune response to JX-594 by change in peripheral white blood cell counts over time | 6 weeks |
| Response of tumour markers to JX-594 | Determine serum tumor marker response rate | Weekly |
| Time to progressive disease | Determine time to progression of disease after JX-594 administration | 6 weeks |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |