Clinical trial NCT02714374: GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Organ Cancers
Keywords: 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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Genelux Corporation
First posted: 2016-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
timeFrame: 2.5 years
Secondary outcomes:
measure: The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.
timeFrame: 2.5 years
measure: The maximum concentration (Cmax) of GL-ONC1 in blood after administration
timeFrame: 2.5 years
measure: Level of anti-vaccinia neutralizing antibodies in serum
timeFrame: 2.5 years
measure: Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue
timeFrame: 2.5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Kaitlyn Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: