NCT03420430

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

First QC Date

January 29, 2018

Last Update Submit

September 23, 2024

Conditions

Interventions

GL-ONC1BIOLOGICAL

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations