Actively Recruiting
HPV Vaccine, Imiquimod, and Metformin Combination Trial
Led by Baylor College of Medicine · Updated on 2024-11-13
85
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
H
Harris Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to explore whether additional treatments can help strengthen the participant's immune system to fight cancer caused by the Human Papillomavirus (HPV), a virus spread through intimate skin-to-skin contact. The trial will also monitor the safety of these treatments. The main questions it aims to answer are: Does the combination of treatments help the participant's body fight the cancer more effectively when used alongside standard therapy? What side effects or medical issues arise when using these experimental treatments? Researchers will use three experimental therapies along with the participant's standard treatment to find out if these therapies work better together than standard treatment alone. Participants will: Receive HPV vaccinations during the 2nd and 4th week of radiation, and again at weeks 8, 10, 12, and 16 after completing radiation. Have blood samples taken, tumor cells brushed from the surface, and imiquimod cream applied during each visit. Take a daily metformin pill and apply an imiquimod suppository three times a week for two weeks after each visit.
CONDITIONS
Official Title
HPV Vaccine, Imiquimod, and Metformin Combination Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed locally advanced or metastatic cervical carcinoma (Stage IB2-IVB), vaginal, or vulvar carcinoma (Stage II-IVB), and not be candidates for primary surgery
- Participants must have measurable disease based on Recist criteria with recent radiological evaluation
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- Participants must be aged 18 years or older
- Adequate organ function within 28 days before registration, as defined by specific blood counts and liver/kidney function tests
- Stable corticosteroid dose for at least 4 weeks before starting treatment if applicable
- Agreement to not donate blood during the study and for 90 days after last treatment dose
- Negative pregnancy test within 14 days prior to registration for females of childbearing potential
- Agreement to not breastfeed during the study
- Ability to understand and consent to study procedures
- Eligibility for chemoradiation treatment as determined by the treating investigator
- HIV-positive participants must have CD4 counts above 200/dL and documented antiretroviral therapy compliance
- Recent CT or PET-CT scan within 56 days before registration
- Newly diagnosed patients
- Standard chemoradiation permitted depending on cancer type with accessible lesion for injection
- ECOG performance status 2 or less (Karnofsky 60% or higher)
- Controlled hepatitis B virus infection with undetectable viral load if on therapy
- Treated and cured or currently treated hepatitis C virus infection with undetectable viral load
- Treated brain metastases with no progression on imaging
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessment
You will not qualify if you...
- Receiving other investigational agents
- Untreated, new, or progressive brain metastases or leptomeningeal disease
- History of allergic reaction to similar compounds used in the study
- Uncontrolled intercurrent illness
- Psychiatric or social conditions limiting compliance with study requirements
- Pregnant women
- Breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77054
Not Yet Recruiting
2
Harris Health Smith Clinic
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
K
Keneshia K Lane, B.A.
CONTACT
K
Kathleen Pennington, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here