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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Alan Brisendine, BS, CCRPemail@example.com|
|Contact: Jasmin Brooksfirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Alan Brisendine, BS, CCRP 843-792-9007 email@example.com|
|Contact: Jasmin Brooks firstname.lastname@example.org|
|Principal Investigator: Angela Yoon, DDS|
|Sub-Investigator: John Kaczmar, MD|
|Principal Investigator:||Angela Yoon, DDS||Medical University of South Carolina|