HPV Vaccine, Imiquimod, and Metformin Combination Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

August 23, 2024

Primary Completion Date

August 23, 2026

Study Completion Date

August 23, 2028

Conditions
Cervical CarcinomaVaginal CarcinomaVulvar CarcinomaHPV (Human Papillomavirus)-Associated Carcinoma
Interventions
DRUG

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.

Trial Locations (2)

77054

NOT_YET_RECRUITING

Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer Center, Houston

RECRUITING

Harris Health Smith Clinic, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Harris Health

UNKNOWN

collaborator

Dan L Duncan Comprehensive Cancer Center

UNKNOWN

collaborator

Baylor St. Luke's Medical Center

OTHER

lead

Baylor College of Medicine

OTHER