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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
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 moreTrial 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.
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Who is running the clinical trial?
Genelux CorporationIndustry Sponsor
6 Previous Clinical Trials
299 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,939 Previous Clinical Trials
588,838 Total Patients Enrolled
Valerie Rusch, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer with fluid in the chest that allows for treatment directly into the pleura.I am taking medication active against vaccinia virus during the study.I have had an organ transplant.I am 18 years old or older.I have had my spleen removed.I have serious skin conditions or unhealed wounds.I do not have a fever or any active infections, including HIV or hepatitis.I am on immunosuppressive therapy or have an autoimmune disease.I do not have any severe health or mental conditions that could worsen by joining this study.I am allergic to eggs and egg products.I am mentally capable of understanding and giving informed consent.I am not currently taking any experimental cancer treatments.I stopped my cancer treatment more than a week ago, except for certain allowed therapies.All side effects from my previous cancer treatments have mostly gone away.I do not have severe heart disease.I have not had gene therapy or virus-based cancer treatments before.I had surgery with general anesthesia over 2 weeks ago.My latest brain scan shows no worsening of my stage IV cancer.I can take care of myself and am up and about more than 50% of my waking hours.I am not pregnant.I am taking more than 20 mg/day of steroids.
Research Study Groups:
This trial has the following groups:- Group 1: GL-ONC1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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