Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date January 29, 2018
First Posted Date February 2, 2018
Last Update Posted Date February 2, 2018
 
Descriptive Information
Brief Title Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care
Official Title Use of GL-ONC1 in Patients With Advanced Cancers With No Standard of Care
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition
  • Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)
  • Acute Myeloid Leukemia (6 Patients)
Intervention Biological: GL-ONC1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Contacts
Contact: Susan Coakley 407-303-2090 susan.coakley@flhosp.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03420430
Other Study ID Numbers GL-ONC1-021
Responsible Party Genelux Corporation
Study Sponsor Genelux Corporation
Collaborators Not Provided
Investigators Not Provided
PRS Account Genelux Corporation
Verification Date January 2018