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

NCT00794131 | Completed Phase 1 DMC

• 1 other identifier: GL-ONC1-002/MA
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancers (Solid Tumors)

Keywords

cancer; vaccinia virus; vaccinia; oncolytic; oncolytic virus; biological; imaging

Outcome Measures

Primary Outcomes (1)

• Determine the safety and tolerability of GL-ONC1, administered intravenously to patients with advanced solid tumors.

  Every 30 minutes for 2 hours after each administration of GL-ONC1, then daily until discharge and on day 8, then weekly up to day 21, then week 12 and week 24

Secondary Outcomes (7)

• Detection of virus delivery to primary and/or metastatic tumors by PCR and immunohistochemistry.

  To be performed where tumor is deemed safely accessible for biopsy (requires patient consent). Timing of post-treatment biopsy may vary to optimise data generated, however, within two weeks of administration is considered suitable.

• Evaluation of anti-vaccinia virus immune response (antibody responses)

  To be done at baseline and weekly for the first 8 weeks for all cohorts. A final test will be performed on day 30 after the last virus application.

• Evaluation of viral delivery by fluorescence imaging

  The timing and frequency of visualization will be dependent on the acquired data but may be pursued once weekly for the length of the observation period.

• Determine recommended dose and schedule for future investigation.

  At the end of the study

• Evaluation of anti-tumor activity

  Week 12 and week 24 after each cycle (Cohorts 1-7). Cohort 8, 1B: 15 days (± 3 days),on D 29 (± 3 days) prior to Cycle 2 ;CT: weeks 12, 24

Interventions

GL-ONC1 BIOLOGICAL

a genetically-engineered vaccinia virus (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[SI units 10\^9/L\]
• Haemoglobin ≥ 9.0 g/dL \[SI units gm/L\]
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Bilirubin ≤ 1.5 x ULN
• AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases
• Ejection fraction of ≥50% by MUGA or ECHO.

You may not qualify if:

• 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.
• Prior splenectomy.
• Previous organ transplant.
• Pregnant or breast-feeding women.
• Clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris or myocardial infarction within one year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction (as determined by MUGA).
• Dementia or altered mental status that would prohibit informed consent.

Sponsors & Collaborators

• Genelux GmbH: lead

Study Sites (1)

Royal Marsden Hospital

Surrey, United Kingdom

Location

Related Links

• Click Here for more information about this study: Safety Study of GL-ONC1, an Oncolytic Virus, in Patients with Advanced Solid Tumors

MeSH Terms

Conditions

Neoplasms; Vaccinia

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Johann de Bono, MD FRCP MSc PhD

  Royal Marsdon Hospital/Institute for Cancer Research

  PRINCIPAL INVESTIGATOR

• Kevin Harrington, MBBS MRCP FRCR

  Royal Marsden Hospital/Institute of Cancer Research

  PRINCIPAL INVESTIGATOR

• Hardev Pandha, MD,FRCP,FRACP,PhD

  Surrey Clinical Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

GB (1)