← Back to Search

Topical Imiquimod for Oral Cancer

Phase < 1
Waitlist Available
Led By Angela Yoon, DDS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) =< 2
Previously untreated and biopsy confirmed oral squamous cell carcinoma (OSCC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

This trial will test the effects of Aldara on patients with oral cancer to see if it is an effective treatment. Aldara is a drug that activates the self-destruction of tumor cells and also activates immune cells to attack and eliminate cancer cells. 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).

Who is the study for?
This trial is for adults with early-stage oral squamous cell carcinoma who haven't had treatment yet. They should be in good enough health to participate (ECOG <=2). People can't join if they need immunosuppressive drugs, have other serious illnesses, are pregnant or breastfeeding, or if they're HIV positive on certain treatments.Check my eligibility
What is being tested?
The study tests Aldara cream's effects on oral cancer. It's an 'off-label' use since Aldara is FDA-approved for skin cancer but not oral cancer. The trial will check how well it works before surgery and its impact on the immune system around the tumor.See study design
What are the potential side effects?
Aldara may cause local skin reactions where applied, flu-like symptoms such as fever and fatigue, muscle pain, headaches, and digestive issues. Since it stimulates the immune system, there might also be a risk of autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have a confirmed case of oral cancer that has not been treated.
Select...
My cancer is in an early stage (stage I or II).
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of imiquimod therapy
Secondary outcome measures
Safety of imiquimod therapy
Other outcome measures
Exploratory study

Side effects data

From 2020 Phase 2 trial • 33 Patients • NCT03180684
72%
Injection site pain
56%
Fatigue
48%
Myalgia
40%
Nausea
40%
Injection site bruising
40%
Headache
36%
Injection site swelling
32%
Injection site erythema
24%
Arthralgia
20%
Vulvovaginal pruritis
20%
Injection site pruritis
16%
Dizziness
16%
Malaise
12%
Vulvovaginal discomfort
12%
Diarrhoea
12%
Procedural pain
12%
Vulval disorder
12%
Hypertension
12%
Body temperature increased
8%
Urinary incontinence
8%
Palpitations
8%
Urinary tract infection
8%
Dyspareunia
8%
Rhinitis allergic
8%
Sinus congestion
8%
Alopecia
8%
Decreased appetite
8%
Back pain
8%
Hypoaesthesia
8%
Hot flush
4%
Cellulitis
4%
Pulmonary mass
4%
Ear pain
4%
Depression
4%
Oropharyngeal pain
4%
Pruritus
4%
Ulcer
4%
Pyrexia
4%
Vulvovaginal burning sensation
4%
Vulvovaginal pain
4%
Vomiting
4%
Weight increased
4%
Paraesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
VGX-3100 + EP
VGX-3100 + EP + Imiquimod

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Topical AldaraExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imiquimod 5% Cream
2009
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,817 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,245 Total Patients Enrolled
Angela Yoon, DDSPrincipal InvestigatorMedical University of South Carolina

Media Library

Experimental: Topical Aldara Clinical Trial Eligibility Overview. Trial Name: NCT04883645 — Phase < 1
Oral Cancers Research Study Groups: Experimental: Topical Aldara
Oral Cancers Clinical Trial 2023: Experimental: Topical Aldara Highlights & Side Effects. Trial Name: NCT04883645 — Phase < 1
Experimental: Topical Aldara 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883645 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment process for this research endeavor?

"This clinical trial is actively looking for participants, with its initial posting on April 28th 2022 and most recent edit happening on August 24th. Clinicaltrials.gov has the full details of this study available online."

Answered by AI

Who meets the eligibility criteria to take part in this trial?

"This clinical trial has the capacity to accept 18 individuals with oral cancers aged between 18 and 100. To be eligible, applicants must have had no prior treatment for their biopsy-confirmed OSCC and possess a Clinical (TNM) stage of I or II, an ECOG score less than 2 and meet the age criteria."

Answered by AI

How many participants are being admitted to this experimental trial?

"Affirmative, the information hosted on clinicaltrials.gov displays that this particular trial is proactively searching for participants. The study was opened to recruitment on April 28th 2022 and has been updated most recently in August of 2022. 18 patients are required from 2 different sites."

Answered by AI

What is Imiquimod 5% Cream,Top,Pkt,0.25Gm frequently prescribed for?

"Imiquimod 5% Cream packaged in 0.25Gm tubes can be employed to treat scalp structure, condylomata acuminata and facial irregularities."

Answered by AI

What past experiments have been conducted with Imiquimod 5% Cream,Top,Pkt,0.25Gm?

"Initially studied in 2008 at Dana-Farber Cancer Institute, Imiquimod 5% Cream,Top,Pkt,0.25Gm has since had 74 trials completed and currently boasts 21 active trials; notably many of these are located around Charleston South carolina."

Answered by AI

Could individuals over the age of 30 qualify to be part of this scientific investigation?

"This clinical trial requires participants to be between 18 and 100 years old. For individuals outside of this range, there are alternatives: 6 trials for those younger than 18 and 91 available for seniors aged 65 or higher."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Topical Aldara (Imiquimod) for Oral Cancer
Angela Yoon 2022. "Topical Aldara (Imiquimod) for Oral Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04883645.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top