This phase I trial studies the side effects of copaxone in treating patients with tumors that can be accessed through the skin (percutaneously accessible). Immunotherapy with copaxone, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Copaxone may show positive changes in the number of white blood cells (the cells that fight infection and cancer) that leave the bloodstream and head of toward a tumor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03982212.
PRIMARY OBJECTIVE:
I. To determine safety and tolerability of intratumoral injection of glatiramer acetate (copaxone) in patients with percutaneously accessible tumors.
SECONDARY OBJECTIVE:
I. To measure the effect of intratumoral injection of copaxone on biomarker levels before and after treatment.
EXPLORATORY OBJECTIVE:
I. To detect early efficacy signal by measuring changes in the level of Ki-67 and caspase-3 before and after treatment with copaxone.
OUTLINE:
Within 1-3 weeks prior to standard of care surgery, patients receive glatiramer acetate intratumorally for at least 1 and up to 3 doses with each dose being at least 48 hours apart and last dose within 96 hours of surgery in the absence of disease progression or unacceptable toxicity.
Lead OrganizationUniversity of Kansas Clinical Research Center
Principal InvestigatorJoaquina Celebre Baranda