Clinical Trials /

Topical Aldara (Imiquimod) for Oral Cancer

NCT04883645

Description:

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.

Related Conditions:
  • Oral Cavity Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT04883645

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: AAAT5562
  • SECONDARY ID: CA252441
  • NCT ID: NCT04883645

Conditions

  • Oral Cancer

Interventions

DrugSynonymsArms
Imiquimod 5% Cream,Top,Pkt,0.25GmExperimental: Topical Aldara

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Experimental: Topical AldaraExperimentalAll 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.
  • Imiquimod 5% Cream,Top,Pkt,0.25Gm

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).
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:up to 17 months
Safety Issue:
Description:The primary endpoint is the overall response rate as defined as the best response (CR and PR), confirmed at 4 weeks of the start of study therapy, using RECIST v1.1 criteria neoadjuvant setting in patients with early-stage oral squamous cell carcinoma.

Secondary Outcome Measures

Measure:Overall rate of toxicity
Time Frame:up to 17 months
Safety Issue:
Description:The secondary endpoint is defined as safety and toxicity assessed using CTCAE v5.0 criteria. CTCAE v5 criteria.
Measure:Responsoe Rate of topical imiquimod
Time Frame:up to 17 months
Safety Issue:
Description:We will estimate response rate to topical imiquimod using the exact 95% confidence interval based on the binomial distribution. microenvironment by performing quantitative multiplex immunofluorescence.

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Columbia University

Last Updated

September 1, 2021