Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03420430
  4. Details
NCT03420430 Clinical Trial

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

Acute Myeloid Leukemia (6 Patients) Clinical Trial

Official title:
Use of GL-ONC1 in Patients With Advanced Cancers With No Standard of Care

Clinical Trial Details — Status: Temporarily not available

Administrative data
NCT number NCT03420430
Other study ID # GL-ONC1-021
Secondary ID
Status Temporarily not available
Phase
First received
Last updated

Study information
Verified date June 2023
Source Genelux Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Temporarily not available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

  • Acute Myeloid Leukemia (6 Patients)
  • Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)

Intervention

Biological:
• GL-ONC1

Locations
Country Name City State
United States Florida Hospital Cancer Institute Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
Genelux Corporation

Country where clinical trial is conducted

United States, 

External Links