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

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: NCT02714374
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Genelux Corporation
Information provided by (Responsible Party):
Kaitlyn Kelly, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 2, 2016
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date June 27, 2017
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
Number of participants with treatment-related adverse events as defined by CTCAE v4.03. [ Time Frame: 2.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02714374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen. [ Time Frame: 2.5 years ]
  • The maximum concentration (Cmax) of GL-ONC1 in blood after administration [ Time Frame: 2.5 years ]
  • Level of anti-vaccinia neutralizing antibodies in serum [ Time Frame: 2.5 years ]
  • Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue [ Time Frame: 2.5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • The presence of GL-ONC1 within malignant tumors after bolus intravenous (IV) injection by examination of the resected surgical specimen when applicable. [ Time Frame: 2.5 years ]
  • The area under the concentration versus time curve from time zero to 120 min following each administration of GL-ONC1. [ Time Frame: 2.5 years ]
  • Caspase-3 expression in pre-treatment biopsy specimen and post-treatment resected tumor tissue. [ Time Frame: 2.5 years ]
  • The maximum concentration (Cmax) of GL-ONC1 in blood after administration. [ Time Frame: 2.5 years ]
  • Ki-67 proliferation index in pretreatment biopsy tissue and post-treatment resected tumor tissue. [ Time Frame: 2.5 years ]
  • Level of anti-vaccinia neutralizing antibodies in serum [ Time Frame: 2.5 years ]
  • Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue [ Time Frame: 2.5 years ]
  • The time to reach maximum concentration (Tmax) of GL-ONC1 in blood after administration. [ Time Frame: 2.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effect of GL-ONC1 Administered IV Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Organ Cancers
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: GL-ONC1
Cohort 3, 5, 7, 8, 9
Intervention: Biological: GL-ONC1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714374
Other Study ID Numbers  ICMJE 151060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaitlyn Kelly, MD, University of California, San Diego
Study Sponsor  ICMJE Kaitlyn Kelly, MD
Collaborators  ICMJE Genelux Corporation
Investigators  ICMJE
Principal Investigator: Kaitlyn Kelly, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP