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Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors

Phase I Study of the Safety, Tolerability,and Tumor-Specific Replication of the Intravenous Administration of Green Fluorescent Protein Encoded Genetically Engineered Attenuated Vaccinia Virus, GL-ONC1, in Patients With Advanced Solid Organ Cancers.

NCT00794131•Genelux GmbH

View on ClinicalTrials.gov

Summary

The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can safely be administered intravenously in patients with advanced solid tumors.

Detailed Description

In preclinical studies, GL-ONC1 an oncolytic vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor cells. This study seeks to evaluate the safety profile of an attenuated vaccinia virus when administered intravenously to patients with advanced solid tumors. The study also seeks to detect virus delivery to primary and/or metastatic tumors, including evaluation of viral delivery by fluorescence imaging (GFP expression); whether anti-vaccinia virus immune response occurs; and will record evidence of any anti-tumor activity. For Cohorts 8 and Expansion Cohort 1B, CTC counts, virus-encoded marker gene analysis and Dynamic Contrast (DCE-MRI) MRI imaging will be used to evaluate tumor micro-circulation in vivo. These measures will be evaluated for their potential predictive value of survival outcomes, and to evaluate any correlation of such pharmacodynamic and response rate indicators in the GL-ONC1 treatment context.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of histologically or cytologically documented, advanced stage, primary or metastatic solid tumors refractory to standard therapy or for which no curative standard therapy exists.
•Evidence of measurable or evaluable disease.
•Age must be ≥ 18 years.
•All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤ 1. Surgery must have occurred at least 28 days prior to study enrolment.
•Chemotherapy or radiotherapy (other than small-field palliative radiotherapy), immunotherapy and/or hormonal therapy must have been received \> 28 days prior to receiving study drug. Subjects may continue to receive LHRH analogue therapy for prostate cancer in face of rising PSA. Bisphosphonates and anticoagulants are permitted.
•ECOG Performance Score ≤ 1.
•Life expectancy of at least 3 months.
•Required baseline laboratory data include:
•* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 \[SI units 10\^9/L\]
•* Platelets ≥ 100 x 10\^9 \[SI units 10\^9/L\]
+13 more criteria

Exclusion Criteria

•Prior therapy with a cytolytic virus of any type.
•Concurrent therapy with any other investigational anticancer agent.
•Concurrent vaccines or immunotherapy during, and for 30 days before or after, study therapy.
•Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during course of study.
•Patients vaccinated with vaccinia virus within the past 10 years.
•Patients with known brain metastases: due to poor prognosis and risk of developing progressive neurological dysfunction that would confound the evaluation of neurological or other adverse events.
•Patients with known allergy to ovalbumin or other egg products.
•Patients with immune system disorders or who are receiving immunosuppressive therapy or any steroids.
•Patients with clinically significant dermatological disorders, e.g. eczema or psoriasis, or any unhealed skin wounds or ulcers, as assessed by the principal investigator during the screening and during the study.
•Patients with fevers, or any systemic infections, including known HIV infection, hepatitis B or C.
+6 more criteria

Locations (1)

Royal Marsden Hospital

Surrey, United Kingdom

Key Dates

Start Date

November 1, 2008

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

April 24, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Cancers (Solid Tumors)

Interventions

GL-ONC1

BIOLOGICAL