Status:
COMPLETED
Neoadjuvant Imiquimod Immunotherapy for Oral Cancer
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Oral Squamous Cell Carcinoma
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
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 ...
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- an...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04883645
Start Date
April 28 2022
End Date
July 31 2024
Last Update
January 28 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425