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Virus Therapy

GL-ONC1 Vaccine for Malignant Pleural Effusion

Phase 1

Waitlist Available

Led By Valerie Rusch, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the safety of a vaccine for cancer patients with a build-up of fluid in their chest.

Who is the study for?

This trial is for adults over 18 with malignant pleural effusion due to lung cancer or mesothelioma, who can have fluid safely added to their chest cavity. They should not be pregnant, have brain metastases, immune disorders, unhealed wounds, or severe heart disease. Participants must not have had recent major surgery and should be relatively fit (ECOG ≤2).Check my eligibility

What is being tested?

The study tests different doses of GL-ONC1 vaccinia virus directly into the chest cavity to assess safety and effects on malignant pleural effusion caused by cancer.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to viral therapy such as fever, fatigue, skin irritation at injection site and flu-like symptoms. Since it's a live virus being used for treatment there might also be a risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Secondary outcome measures

Therapeutic efficacy

detection of virus in body fluids

evaluation of viral appearance in tumor

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: GL-ONC1Experimental Treatment1 Intervention

This is an open-label, dose-escalating, non-randomized, single-center Phase I therapeutic study of GL-ONC1 originally administered intrapleurally as a single dose and now escalating to three consecutive daily doses in patients with a diagnosis (histologically or cytologically documented) of malignant pleural effusions.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Genelux CorporationIndustry Sponsor

6 Previous Clinical Trials

299 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,602 Total Patients Enrolled

Valerie Rusch, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

GL-ONC1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01766739 — Phase 1

Lung Cancer Research Study Groups: GL-ONC1

Lung Cancer Clinical Trial 2023: GL-ONC1 Highlights & Side Effects. Trial Name: NCT01766739 — Phase 1

GL-ONC1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01766739 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior research has been done on GL-ONC1?

"Currently, only 1 clinical trial is in progress to evaluate the efficacy of GL-ONC1. This Phase 3 study has yet to reach its conclusion and primarily takes place in New york City with an additional research site located elsewhere."

Answered by AI

Are researchers currently enrolling participants in this research endeavor?

"At this time, the clinical trial is not actively searching for participants. It was initially made available on 1/1/2013 and most recently modified on 2/7/2022. Fortunately, there are still 572 studies that require individuals with pleural effusion, malignant diseases and a single study recruiting patients to participate in GL-ONC1 trials."

Answered by AI

To what extent can exposure to GL-ONC1 be detrimental to human health?

"The safety of GL-ONC1 is tentatively rated a 1 due to the lack of evidence from preclinical and clinical trials."

Answered by AI

Has this trial been previously attempted in any other capacity?

"Presently, 1 trial for GL-ONC1 is active in a single city and country. Way back in 2013, Genelux Corporation sponsored the first such study with 18 participants, which successfully achieved Phase 1 drug approval status. Since then, no studies have been concluded."

Answered by AI

To what extent is this experiment being participated in by patients?

"Unfortunately, this trial has already reached its recruitment quota. Originally posted on January 1st 2013 and last edited February 7th 2022, current search results reveal that there are 572 clinical trials for pleural effusion malignant and one study for GL-ONC1 presently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma

2013. "Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01766739.

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