Status:
NO_LONGER_AVAILABLE
Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care
Lead Sponsor:
Genelux Corporation
Conditions:
Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)
Acute Myeloid Leukemia (6 Patients)
Eligibility:
All Genders
21+ years
Brief Summary
GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood ...
Eligibility Criteria
Inclusion
- Diagnosis of advanced cancers with no standard of care option for treatment.
- Willing and able to provide written, signed informed consent.
- Use of adequate contraception.
- Negative pregnancy test.
Exclusion
- Have not recovered from severe adverse events from prior therapy.
- Major surgery occurred within 28 days prior to treatment.
- Known immune system disorders such as HIV, or active hepatitis B or C infection.
- Clinically significant cardiac disease (New York Heart Association Class III or IV).
- Have received prior therapy with an oncolytic virus of any type.
- Be receiving antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246).
- Have known allergy to ovalbumin or other egg products.
- Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the treating physician.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03420430
Last Update
September 25 2024
Active Locations (1)
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1
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804