GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers
- Conditions
- Solid Organ Cancers
- Interventions
- Biological: GL-ONC1
- Registration Number
- NCT02714374
- Lead Sponsor
- Andrew Lowy
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GL-ONC1 GL-ONC1 Cohort 3, 5, 7, 8, 9
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as defined by CTCAE v4.03. 2.5 years Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
- Secondary Outcome Measures
Name Time Method The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen. 2.5 years The presence of GL-ONC1 within malignant tumors by examination of the resected
Level of anti-vaccinia neutralizing antibodies in serum 2.5 years Level of anti-vaccinia neutralizing antibodies in serum
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue 2.5 years Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected
The maximum concentration (Cmax) of GL-ONC1 in blood after administration 2.5 years The maximum concentration (Cmax) of GL-ONC1 in blood after administration
Trial Locations
- Locations (1)
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States