Topical Aldara (Imiquimod) for Oral Cancer

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Brief Title

Topical Aldara (Imiquimod) for Oral Cancer

Official Title

Exploratory Clinical Trial of Topical Imiquimod 5% Cream as Window-of-opportunity Monotherapy for Early-stage Oral Cancer

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Overall response rate

Secondary Outcome

 Overall rate of toxicity

Condition

Oral Cancer

Intervention

Imiquimod 5% Cream,Top,Pkt,0.25Gm

Study Arms / Comparison Groups

 Experimental: Topical Aldara
Description:  All patients receive the same treatment (there is no "placebo" arm). Treatment will be self-administered by the patients on an outpatient basis. All patients with untreated and biopsy confirmed oral squamous cell carcinoma (OSCC) who meet the inclusion criteria.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

September 2021

Completion Date

June 2023

Primary Completion Date

May 2023

Eligibility Criteria

        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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Angela Yoon, DDS, 212-305-7676, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04883645

Organization ID

AAAT5562

Secondary IDs

CA252441

Responsible Party

Principal Investigator

Study Sponsor

Columbia University


Study Sponsor

Angela Yoon, DDS, Principal Investigator, Columbia University


Verification Date

August 2021