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Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01394939
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Collaborator:
Transgene
Information provided by (Responsible Party):
SillaJen, Inc. ( Jennerex Biotherapeutics )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Carcinoma CRC Biological: JX-594 Drug: Irinotecan Phase 1 Phase 2

Detailed Description:
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : January 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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

 Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
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

 Biological: JX-594
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.

 Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Drug: Irinotecan
180 mg/m2 IV every 2 weeks.
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.

 Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Drug: Irinotecan
180 mg/m2 IV every 2 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394939


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5499
United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-1651
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
The Ohio State University
Columbus, Ohio, United States, 43210
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital and Research Institute (OHRI)
Ottawa, Ontario, Canada, K1H 8L6
France
Hôpital Saint Antoine
Paris, France, 75012
Hôpital Hautepierre
Strasbourg, France, 67200
Institut Claudius Regaud
Toulouse, France, 31052
Sponsors and Collaborators
Jennerex Biotherapeutics
Transgene
Investigators
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Study Director: James Burke, MD Jennerex Biotherapeutics
Principal Investigator: Derek Jonker, MD Ottawa Hospital and Research Institute
More Information
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Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT01394939    
Other Study ID Numbers: JX594-CRC019
First Posted: July 15, 2011    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: January 8, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SillaJen, Inc. ( Jennerex Biotherapeutics ):
Jennerex
Vaccinia
Vaccinia Virus
JX-594
Colorectal Carcinoma
Colorectal cancer
Colon Cancer
Rectal Cancer
oncolytic virus
 viral therapy
RAS mutant
Erbitux failure
Oxaliplatin failure
FOLFOX failure
FOLFIRI failure
Irinotecan failure
Pexa-Vec
Additional relevant MeSH terms:
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Vaccinia
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents