- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394939
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital and Research Institute (OHRI)
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Paris, France, 75012
- Hôpital Saint Antoine
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Strasbourg, France, 67200
- Hôpital Hautepierre
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Toulouse, France, 31052
- Institut Claudius Regaud
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Arizona
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Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic
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California
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La Jolla, California, United States, 92093
- UCSD Moores Cancer Center
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Montana
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Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-1651
- University of North Carolina
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
- Failed treatment with irinotecan
- Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
- Regorafenib-naïve (have not received regorafenib)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
- Measurable tumor (≥1 cm longest diameter)
- Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation)
Exclusion Criteria:
- Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
- Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
- Significant immunodeficiency due to underlying illness and/or medication
- History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
- Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
- Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
- Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms
- Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas)
- Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment
- Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose
- Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
- Pregnant or nursing an infant
- Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single Agent_ Cohort 1
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29 |
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
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Experimental: Single Agent_Cohort 2
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 |
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
|
Experimental: Combination_Cohort 3
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
180 mg/m2 IV every 2 weeks.
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Experimental: Combination_Cohort 4
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: RAC VAC GM-CSF JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
180 mg/m2 IV every 2 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
Time Frame: Scans Every 8 weeks until radiographic progression was confirmed by the site.
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Percentage of participants who showed overall response during their participation in the study.
Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
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Scans Every 8 weeks until radiographic progression was confirmed by the site.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: James Burke, MD, Jennerex Biotherapeutics
- Principal Investigator: Derek Jonker, MD, Ottawa Hospital and Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- DNA Virus Infections
- Intestinal Neoplasms
- Rectal Diseases
- Poxviridae Infections
- Carcinoma
- Colorectal Neoplasms
- Vaccinia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- JX594-CRC019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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