Safety and Effect of GL-ONC1 Administered IV With or Without Eculizumab Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02714374

Safety and Effect of GL-ONC1 Administered IV With or Without Eculizumab Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The purpose of this study is to test the effects, good and/or bad, of the investigational product, GL-ONC1, alone or in combination with eculizumab. This study aims to find the highest dose of GL-ONC1 that can be given alone, or with eculizumab, without causing unacceptable side effects. GL-ONC1 is considered experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of any disease. Eculizumab is approved by the FDA for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS). Eculizumab is considered experimental in this study because it is not approved by the FDA for the treatment of cancer.

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 very successfully in the past as smallpox vaccine in many millions of people worldwide. Eculizumab is a type of drug called a monoclonal antibody. This drug is designed to inhibit the activity of a protein called complement. Complement is part of the body's immune system that destroys and removes foreign particles. Evidence from laboratory tests suggest eculizumab may allow GL-ONC1 to stay in the body longer before being cleared by the immune system, which may help destroy more cancer cells.

Status: 
Recruiting
Study Date: 
Tue, 03/01/2016 to Thu, 03/15/2018
Bone Marrow Disease(s): 
paroxysmal nocturnal hemoglobinuria (PNH)
Associated Drug(s): 
Intervention: 
Drug: GL-ONC1 Dose and Regimen: Single dose group: Cohort 1 dose is 1 × 109 pfu Multiple dose groups: (1) Cohort 2 dose is 1 × 109 pfu × 5 consecutive days; (2) Cohorts 3 and 4 dose is 2 × 109 pfu × 5 consecutive days; or (3) Cohorts 5 and 6 dose escalates at 2,3,5,5,5 × 109 pfu. Route: GL-ONC1 is delivered as a bolus IV injection. Drug: Eculizumab Dose and Regimen: With the exception of Cohorts 3 and 5, eculizumab is administered as a single dose on Week 1/Day 1 at 900 mg 60-90 minutes prior to GL-ONC1. An additional 3 patients may be enrolled into Cohorts -1 to 2 as a control without eculizumab treatment if positive PK of virus in blood is observed, and/or positive VPA of virus is confirmed in excised tumors. In Cohorts 2, 4 and 6, additional patients may receive eculizumab on Week1/Day 2 or Week 1/Day 3 rather than Week 1/Day 1. For patients undergoing surgery (at the discretion of the Principal Investigator (PI) > 10 days following completion of virus treatment, an additional, maintenance dose of Eculizumab (600 mg) is given 14 to 17 days following administration of the initial eculizumab dose. Route: Eculizumab is administered intravenously. Other Name: Soliris