Topical Aldara (Imiquimod) for Oral Cancer

  • End date
    Mar 31, 2023
  • participants needed
  • sponsor
    Medical University of South Carolina
Updated on 25 May 2022
squamous cell carcinoma
tumor cells
oral cancer


The purpose of this research study is to find out what effects, good and/or bad, topical application of the drug Aldara will have on patients and on their oral cancer. Aldara is a drug that activates toll-like receptor (TLR) in oral cancer cells causing self-destruction of tumor cells. It also activates immune cells to attack and eliminate cancer cells. Aldara is currently approved by the Food and Drug Administration (FDA) for treatment of skin cancer and melanoma. Its use in this study is 'off-label' (use of a drug approved by FDA for skin cancer to treat oral cancer in this study).

To assess the preliminary efficacy of topical imiquimod in neoadjuvant setting in patients with early-stage oral squamous cell carcinoma as determined by best response rate (CR and PR). To assess local and systemic safety and tolerability by CTCAE v5 criteria. To explore the effect of imiquimod on the tumor immune microenvironment by performing quantitative multiplex immunofluorescence.


The researchers propose an exploratory clinical trial to evaluate the efficacy of topical imiquimod, a TLR-7 agonist, in patients with early-stage oral squamous cell carcinoma. The analysis of pre- and post-treatment tumor specimen collected from patients treated on this study will be used for quantitative immunoflourescence analysis to assess the immunomodulatory activity of imiquimod in human tumor samples. The researchers hypothesize that TLR-7 stimulation will reduce the size of the tumor in patients with early-stage oral squamous cell carcinoma. The researchers anticipate that activation of CD4+ (cluster of differentiation 4+) T-cell and macrophage will correlate with response to therapy.

Condition Oral Cancer
Treatment Imiquimod 5% Cream,Top,Pkt,0.25Gm, Imiquimod 5% Cream,Top,Pkt,0.25Gm
Clinical Study IdentifierNCT04883645
SponsorMedical University of South Carolina
Last Modified on25 May 2022


Yes No Not Sure

Inclusion Criteria

Previously untreated and biopsy confirmed oral squamous cell carcinoma (OSCC)
Clinical (TNM) stage I or II
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) =< 2

Exclusion Criteria

Patients associated with prior therapy requiring treatment with systemic immunosuppressive treatments with the exception of vitiligo, childhood asthma that has resolved, residual endocrinopathies requiring replacement therapy, or psoriasis that does not require systemic treatment
Treatment with any other investigational agents
Requirement for immunosuppressive intraoral topical or systemic corticosteroids prior to the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
HIV positive patients on combination antiretroviral therapy
Have evidence of any other significant oral mucosal condition, clinical disorder, physical examination finding, or laboratory finding that, as judged by the investigator, makes it undesirable for the patient to participate in the study
Pregnant women are excluded from this study because imiquimod may have adverse effect on the fetus (FDA pregnancy risk category C). Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with imiquimod, breastfeeding should be discontinued if the mother is receiving study treatment
Male patients unwilling or unable to comply with pregnancy prevention measures
Subjects not receiving initial surgical treatment at Columbia University Irving Medical Center (CUIMC)
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