HPV Vaccine, Imiquimod, and Metformin Combination Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06686043
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cervical Carcinoma
  • HPV (Human Papillomavirus)-Associated Carcinoma
  • Vaginal Carcinoma
  • Vulvar Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • HPV vaccine, Imiquimod, and metformin combination therapy — DRUG
    Participants in the treatment arm will have visits during the 2nd and 4th weeks of radiation, and then at weeks 8, 10, 12, and 16 after radiation. At each visit, a blood sample will be taken, and tumor cells collected using a cytobrush (or directly from the tumor for vulvar cancer). An HPV vaccine will be injected into the tumor, imiquimod cream will be applied topically, and participants will receive a subcutaneous vaccine shot. They will also take metformin tablets twice daily for two weeks and apply imiquimod cream at home three nights per week. Follow-up PET/CT scans will occur at week 20 and two years post-treatment, with exams every three months for two years.

Study Details

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.

Key Dates

Start date
Aug 23, 2024
Status verified
Nov 2024
Primary completion
Aug 23, 2026
Completion
Aug 23, 2028

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    The treatment group will be compared to a historical control. The investigator will evaluate the immune changes within the tumor microenvironment and validate why the combination immunotherapy study elicited such a robust immune response which led to complete resolution of the cancer, in comparison to the standard of care, chemoradiation. In this study, participants will undergo a series of treatment visits during and after radiation therapy to assess the effectiveness of the experimental combination therapy.

Primary Outcome Measure

Progression free survival [ Time Frame: 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer CenterHoustonTexas77054
Keneshia K Lane, B.A.
[email protected]
832-826-8071
Jan S Sunde, MD
[email protected]
206-778-9253
Jan S Sunde, MD (PRINCIPAL_INVESTIGATOR)
Harris Health Smith ClinicHoustonTexas77054
Keneshia K Lane, B.A
[email protected]
832-826-8071
Jan S Sunde, MD
[email protected]
206-778-9253
Jan S Sunde, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer Center· Houston, TXHarris Health Smith Clinic· Houston, TX

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