Safety and Effect of GL-ONC1 Administered IV Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery

March 23, 2020 updated by: Kaitlyn Kelly, MD

An Open Label, Non-randomized Phase 1b Study to Investigate the Safety and Effect of the Oncolytic Virus GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery for Curative-Intent or Palliative Resection

The purpose of this study is to evaluate the safety of the investigational product GL-ONC1. GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, non-randomized Phase 1b dose escalation study evaluating the safety and effect of the oncolytic virus GL-ONC1 administered intravenously, with or without eculizumab, prior to surgery in patients with advanced solid organ tumors.

GL-ONC1 is a genetically engineered oncolytic vaccinia virus, which disrupts nonessential genes and expression of the foreign gene expression. Evidence suggest that GL-ONC1 is able to infect tumor tissue and kill tumor cells.

The goals of this study are to evaluate the safety of GL-ONC1 and to assess the pharmacokinetics and pharmacodynamics profile of GL-ONC1 in vivo.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • 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

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically-proven diagnosis of advanced (AJCC, 7th Edition: stage III or IV) or aggressive solid organ cancer.
  • Patients must provide written consent for a core needle biopsy sample of tumor tissue (primary or metastatic).
  • Have evidence of measurable disease (according to RECIST Version 1.1: http:// www.recist.com).
  • Have an ECOG Performance Score of 0 to 2.
  • Have a life expectancy of at least 3 months.
  • Have adequate organ and marrow function
  • Negative serum pregnancy test for females of childbearing potential.
  • Have negative test result for HIV and Hepatitis B or C testing.
  • Have baseline anti-vaccinia antibody titer < 10.

Exclusion Criteria:

  • Current or anticipated use of other investigational agents or marketed anticancer agent while on study (from the time of enrollment through the time of surgery).
  • Patients who have received chemotherapy or radiotherapy within 4 weeks prior to entering the study.
  • Small pox vaccination for 4 weeks before study therapy and during study treatment.
  • Have received prior gene therapy or therapy with cytolytic virus of any type.
  • Have clinically significant cardiac disease
  • Oxygen saturation <90% measured by pulse oximetry at rest.
  • Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during the course of study.
  • Have known allergy to ovalbumin or other egg products.
  • Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers)
  • Have a history of allergy to iodinated contrast media.
  • Patients with known brain metastases
  • Pregnant or nursing

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GL-ONC1
Cohort 3, 5, 7, 8, 9
Biological: GL-ONC1

Dose and Regimen:

  1. Single dose group: Cohort 1 dose is 1 × 109 pfu

  2. Multiple dose groups:

    • Cohort 2 dose is 1 × 109 pfu × 5 consecutive days
    • Cohorts 3 and 4 dose is 2 × 109 pfu × 5 consecutive days
    • Cohorts 5 and 6 dose escalates at 2,3,5,5,5 × 109 pfu.

Route: GL-ONC1 is delivered as a bolus IV injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
Time Frame: 2.5 years
2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.
Time Frame: 2.5 years
2.5 years
The maximum concentration (Cmax) of GL-ONC1 in blood after administration
Time Frame: 2.5 years
2.5 years
Level of anti-vaccinia neutralizing antibodies in serum
Time Frame: 2.5 years
2.5 years
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

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

Sponsor

Kaitlyn Kelly, MD

Collaborators

Genelux Corporation

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 (Actual)

March 25, 2016

Primary Completion (Actual)

August 6, 2019

Study Completion (Actual)

August 6, 2019

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 151060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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