NCT04883645CompletedEarly phase 1
Neoadjuvant Imiquimod Immunotherapy for Oral Cancer
Pilot Clinical Trial of Neoadjuvant Toll-like Receptor 7 Agonist (Imiquimod) Immunotherapy in Early-Stage Oral Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 28 Jan 2025
Brief summary (registry, in English)
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). The preliminary efficacy of topical imiquimod in a neoadjuvant setting in patients with early-stage oral squamous cell carcinoma will be determined by a reduction in tumor cellularity in post-treatment tissue compared to pre-treatment tissue. Safety and tolerability will be evaluated by CTCAE v5 criteria. The effect of imiquimod on the tumor immune microenvironment will be assessed by performing quantitative multiplex immunofluorescence.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 6 May 2021
- Start date
- 28 Apr 2022
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Head and neck cancer
- NCT number
- NCT04883645
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 16
- From 28 Apr 2022 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Subjects not receiving initial surgical treatment at Medical University of South Carolina (MUSC)
Other illness
- 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
Lab values
- 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
Other
- Male patients unwilling or unable to comply with pregnancy prevention measures
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.