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.
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
Interventions
Drug | Synonyms | Arms |
---|
Imiquimod 5% Cream,Top,Pkt,0.25Gm | | Experimental: 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
Name | Type | Description | Interventions |
---|
Experimental: Topical Aldara | Experimental | 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. | - 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