GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers (NCT02714374) | Clinical Trial Compass
TerminatedPhase 1
GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers
Stopped: Insufficient funding
United States5 participantsStarted 2016-03-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.