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

December 11, 2020 updated by: Jennerex Biotherapeutics

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital and Research Institute (OHRI)
  • France
      • Paris, France, 75012
        • Hôpital Saint Antoine
      • Strasbourg, France, 67200
        • Hôpital Hautepierre
      • Toulouse, France, 31052
        • Institut Claudius Regaud
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-1651
        • University of North Carolina
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Scans Every 8 weeks until radiographic progression was confirmed by the site.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennerex Biotherapeutics

Collaborators

Transgene

Investigators

  • Study Director: James Burke, MD, Jennerex Biotherapeutics
  • Principal Investigator: Derek Jonker, MD, Ottawa Hospital and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JX594-CRC019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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