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Topical Aldara (Imiquimod) for Oral Cancer

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ClinicalTrials.gov Identifier: NCT04883645
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.


Condition or disease Intervention/treatment Phase
Oral Cancer Drug: Imiquimod 5% Cream,Top,Pkt,0.25Gm Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Clinical Trial of Topical Imiquimod 5% Cream as Window-of-opportunity Monotherapy for Early-stage Oral Cancer
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer
Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Experimental: Topical Aldara
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.
Drug: Imiquimod 5% Cream,Top,Pkt,0.25Gm
Imiquimod as a 5% cream is being used to treat several skin cancers, including malignant melanoma, basal cell carcinoma (BCC) and SCC26-28. With respect to SCC treatment, it has been demonstrated that imiquimod stimulates tumor destruction by recruiting T cells (cells in the immune system) from blood and by inhibiting tonic anti-inflammatory signals within the tumor. The patient will be instructed to apply imiquimod cream, 7 nights a week for 4 weeks to the oral tumor at bedtime.




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 17 months ]
    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 :
  1. Overall rate of toxicity [ Time Frame: up to 17 months ]
    The secondary endpoint is defined as safety and toxicity assessed using CTCAE v5.0 criteria. CTCAE v5 criteria.

  2. Responsoe Rate of topical imiquimod [ Time Frame: up to 17 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883645


Contacts
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Contact: Alan Brisendine, BS, CCRP 843-792-9007 brisend@musc.edu
Contact: Jasmin Brooks brooksjm@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alan Brisendine, BS, CCRP    843-792-9007    brisend@musc.edu   
Contact: Jasmin Brooks       brooksjm@musc.edu   
Principal Investigator: Angela Yoon, DDS         
Sub-Investigator: John Kaczmar, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Angela Yoon, DDS Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04883645    
Other Study ID Numbers: AAAT5562
CA252441 ( Other Grant/Funding Number: NCI )
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers