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Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care

Sponsor
Genelux Corporation (Industry)
Overall Status
No longer available
CT.gov ID
NCT03420430
Collaborator
(none)
1
Location

Study Details

Study Description

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 cancer, with no standard of care options for treatment. Potential patients will be evaluated individually depending on GL-ONC1 product supply.

Condition or Disease Intervention/Treatment Phase
  • Biological: GL-ONC1

Study Design

Study Type:
Expanded Access
Official Title:
Use of GL-ONC1 in Patients With Advanced Cancers With No Standard of Care

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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 Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida Hospital Cancer Institute Orlando Florida United States 32804

    Sponsors and Collaborators

    • Genelux Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Genelux Corporation
    ClinicalTrials.gov Identifier:
    NCT03420430
    Other Study ID Numbers:
    • GL-ONC1-021
    First Posted:
    Feb 5, 2018
    Last Update Posted:
    Aug 1, 2019
    Last Verified:
    Jan 1, 2018

    Study Results

    No Results Posted as of Aug 1, 2019