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Topical Aldara (Imiquimod) for Oral Cancer

Primary Purpose

Oral Cancer

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Imiquimod 5% Cream,Top,Pkt,0.25Gm

About this trial

This is an interventional treatment trial for Oral Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Medical University of South Carolina (MUSC)

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Topical Aldara

Arm 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.

Outcomes

Primary Outcome Measures

Overall response rate

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

Overall rate of toxicity

The secondary endpoint is defined as safety and toxicity assessed using CTCAE v5.0 criteria. CTCAE v5 criteria.

Response Rate of topical imiquimod

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.

Full Information

NCT ID

NCT04883645

First Posted

May 6, 2021

Last Updated

September 15, 2023

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT04883645

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 28, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Topical Aldara

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Imiquimod 5% Cream,Top,Pkt,0.25Gm

Intervention Description

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 Measure Information:

Title

Overall response rate

Description

Time Frame

up to 17 months

Secondary Outcome Measure Information:

Title

Overall rate of toxicity

Description

The secondary endpoint is defined as safety and toxicity assessed using CTCAE v5.0 criteria. CTCAE v5 criteria.

Time Frame

up to 17 months

Title

Response Rate of topical imiquimod

Description

Time Frame

up to 17 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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 Medical University of South Carolina (MUSC)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Yoon, DDS

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Topical Aldara (Imiquimod) for Oral Cancer

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