85
Participants
Start Date
August 23, 2024
Primary Completion Date
August 23, 2026
Study Completion Date
August 23, 2028
HPV vaccine, Imiquimod, and metformin combination therapy
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.
NOT_YET_RECRUITING
Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer Center, Houston
RECRUITING
Harris Health Smith Clinic, Houston
Collaborators (1)
Harris Health
UNKNOWN
Dan L Duncan Comprehensive Cancer Center
UNKNOWN
Baylor St. Luke's Medical Center
OTHER
Baylor College of Medicine
OTHER