Summary

for people ages 18 years and up (full criteria)
at La Jolla, California
study started
estimated completion:
Kaitlyn Kelly

Description

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.

Official Title

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

Details

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.

Keywords

Solid Organ Cancers GL-ONC1 Solid Organ Cancer Cancer Surgery Oncolytic Virus Soliris Metastatic melanoma Esophageal and gastric adenocarcinoma (Stage III/IV) Cholangiocarcinoma Pancreatic adenocarcinoma Gallbladder cancer Colorectal cancer (Stage IV) High-grade mucinous appendix cancer High-grade gastrointestinal neuroendocrine cancer Mesothelioma High-grade soft tissue sarcoma Stage III or IV

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Location

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

Lead Scientist

  • Kaitlyn Kelly
    Assistant Clinical Professor, Surgery. Authored (or co-authored) 33 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kaitlyn Kelly, MD
ID
NCT02714374
Phase
Phase 1
Study Type
Interventional
Last Updated