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Safety and Effect of GL-ONC1 Administered IV Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery

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.

Tracking Information
First Received DateMarch 2, 2016
Last Changed DateJune 26, 2017
Start DateMarch 2016
Anticipated Primary Completion DateMarch 2019
Primary Outcome Measures

Number of participants with treatment-related adverse events as defined by CTCAE v4.03. [Time Frame: 2.5 years]

Secondary Outcome Measures

The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen. [Time Frame: 2.5 years]

The maximum concentration (Cmax) of GL-ONC1 in blood after administration [Time Frame: 2.5 years]

Level of anti-vaccinia neutralizing antibodies in serum [Time Frame: 2.5 years]

Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue [Time Frame: 2.5 years]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Solid Organ Cancers
Intervention
  • Biological: GL-ONC1
Study Arms / Comparison Groups1 / 0
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 Information
Recruitment StatusActive, not recruiting
Anticipated Enrollment36
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT02714374
Responsible Party,
SponsorKaitlyn Kelly, MD
Verification DateJune 2017
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