This early phase I trial studies the effects of imiquimod 5% cream applied to the skin (topically) prior to standard of care surgery for the treatment of stage I-II oral cancer. Imiquimod is a drug that activates toll-like receptor in oral cancer cells causing self-destruction of tumor cells. It also activates immune cells to attack and eliminate cancer cells. Imiquimod applied topically prior to surgery may shrink oral cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04883645.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the preliminary efficacy of topical imiquimod in neoadjuvant setting in patients with early-stage oral squamous cell carcinoma as determined by a minimum of 50% reduction in tumor assessed first by pathologic review and then confirmed with tumor cell count using quantitative immunofluorescence.
SECONDARY OBJECTIVE:
I. To assess local and systemic safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 criteria.
EXPLORATORY OBJECTIVE:
I. To explore the effect of imiquimod on the tumor immune microenvironment (immune profile) by performing quantitative multiplex immunofluorescence.
OUTLINE:
Patients apply imiquimod topically 0.5-2 cm beyond the outlined tumor margins once daily (QD) on days 1-28 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorAngela J. Yoon
