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

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ClinicalTrials.gov Identifier: NCT03420430
Expanded Access Status : Available
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Genelux Corporation

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
Advanced Stage Cancer (Solid Tumor Disease for 4 Patients) Acute Myeloid Leukemia (6 Patients) Biological: GL-ONC1

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




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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420430


Contacts
Contact: Susan Coakley 407-303-2090 susan.coakley@flhosp.org

Locations
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Contact: Susan Coakley    407-303-2090    susan.coakley@flhosp.org   
Principal Investigator: Ahmed Zakari, MD         
Sponsors and Collaborators
Genelux Corporation

Additional Information:
Responsible Party: Genelux Corporation
ClinicalTrials.gov Identifier: NCT03420430     History of Changes
Other Study ID Numbers: GL-ONC1-021
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms