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 range18 Years
SexALL
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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…
What they're measuring
1
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.