Unknown
PHASE1
INTERVENTIONAL
NCT03982212
A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The investigator believes that injecting Copaxone into tumors will help participants immune system fight cancer. This has been studied in mice and has shown encouraging results. Copaxone is a safe medication currently used to treat Multiple Sclerosis (MS) and has very few side effects. To be considered for this trial a tumor must be easy to be injected and must be at least the size of a pea. Participants will be closely monitored for any side effects. Tissue from before surgery will be compared to tissue after the treatment and surgery to be checked for immune response and anti-tumor effects.
Interventions
Name:
Copaxone
Type:
DRUG
Description:
* Agent: Glatiramer acetate (Copaxone®)
* Dose: 40 mg
* Route: Intratumoral injection
* Schedule: At least 1 dose, up to 3 doses, with each dose being at least 48 hours apart and last dose within 96 hours of standard of care surgery.
Primary Outcomes
Measure:
Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
TimeFrame:
up to 6 weeks
Description:
Participants will be evaluated for TRAEs and TRSAEs from the time of the first injection (Day 1) through the time they go to surgery. TRAEs and TRSAEs will be evaluated per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Trial Information
NCT ID
NCT03982212
Status
Unknown
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
University of Kansas Medical Center
Last Updated
December 15, 2025