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.
1 other identifier
interventional
52
3 countries
11
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2012
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
January 8, 2021
CompletedJanuary 8, 2021
December 1, 2020
3.4 years
July 13, 2011
September 14, 2020
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
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.
Scans Every 8 weeks until radiographic progression was confirmed by the site.
Study Arms (4)
Single Agent_ Cohort 1
EXPERIMENTALJX-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
Single Agent_Cohort 2
EXPERIMENTALJX-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
Combination_Cohort 3
EXPERIMENTALJX-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.
Combination_Cohort 4
EXPERIMENTALJX-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.
Interventions
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jennerex Biotherapeuticslead
- Transgenecollaborator
Study Sites (11)
Mayo Clinic
Scottsdale, Arizona, 85259-5499, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-1651, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Ottawa Hospital and Research Institute (OHRI)
Ottawa, Ontario, K1H 8L6, Canada
Hôpital Saint Antoine
Paris, 75012, France
Hôpital Hautepierre
Strasbourg, 67200, France
Institut Claudius Regaud
Toulouse, 31052, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kyoung Soo Ha, Head of Clinical Development
- Organization
- Sillajen Biotherapeutics Inc.
Study Officials
- STUDY DIRECTOR
James Burke, MD
Jennerex Biotherapeutics
- PRINCIPAL INVESTIGATOR
Derek Jonker, MD
Ottawa Hospital and Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
July 15, 2011
Study Start
January 1, 2012
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
January 8, 2021
Results First Posted
January 8, 2021
Record last verified: 2020-12