Outcome and patterns of recurrence for International Federation of Gynecology and Obstetrics (FIGO) stages I and II squamous cell vulvar cancer.
Charuwan Tantipalakorn, Greg Robertson, Donald E Marsden...
https://pubmed.ncbi.nlm.nih.gov/19305336Actively Recruiting
Phase 2
Age: 18Years - 64Years
FEMALE
ID06686043
A Phase 2 Study of HPV L1 Vaccine Combined with Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers
Led by Baylor College of Medicine · Updated on 2024-11-13
85
Participants Needed
2
Research Sites
104 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
Researchers are investigating whether adding certain treatments can help boost the immune system to better fight cancer caused by the Human Papillomavirus (HPV), which spreads through intimate skin contact. This trial focuses on patients with locally advanced cervical, vaginal, or vulvar cancers. It aims to find out if combining these new treatments with standard therapies improves the time patients remain free from cancer progression over 24 months, while also monitoring safety and immune system responses. Participants will receive intratumoral HPV vaccinations during their 2nd and 4th weeks of radiation, then again at weeks 8, 10, 12, and 16 after radiation ends. During each visit, blood samples and tumor cells will be collected, and imiquimod cream will be applied. Participants will take metformin pills twice daily for two weeks and apply imiquimod suppositories three times a week at home. Follow-up PET/CT scans and clinical exams will monitor treatment effects over two years. Throughout the study, immune system markers such as CD4, CD8, NK cells, and HPV viral load will be measured at key points. Researchers will track side effects, immune changes, and progression-free survival. Participants will have regular exams every three months for two years to evaluate their health and treatment response, with the total participation lasting up to two years.
CONDITIONS
Brief Title
HPV Vaccine, Imiquimod, and Metformin Combination Trial
Who Can Participate
Age: 18Years - 64Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed locally advanced or metastatic cervical carcinoma (Stage IB2-IVB), vaginal, or vulvar carcinoma (Stage II-IVB), and not be primary surgical candidates.
- Participants must have measurable disease per Recist criteria with radiological evaluation within 30 days before enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Must be 18 years or older.
- Adequate organ function within 28 days of registration (specific blood counts and liver/kidney function limits).
- Stable corticosteroid dose for at least 4 weeks before starting study therapy.
- Must agree not to donate blood during and for 90 days after the study.
- Female participants of childbearing potential must have a negative pregnancy test within 14 days before registration.
- Must agree not to breastfeed during the study.
- Ability to understand and consent to study procedures.
- Eligible for chemoradiation treatment as determined by the treating investigator.
- HIV-positive participants must have CD4 counts above 200/dL and comply with HAART.
- Must have recent CT or PET-CT within 56 days of registration.
- Newly diagnosed patients only.
- Standard chemoradiation allowed with accessible tumor for intratumoral injection.
- Karnofsky score 60% or higher.
- Patients with controlled hepatitis B or cured hepatitis C are eligible.
- Patients with treated brain metastases without progression.
- Prior or concurrent malignancies allowed if they do not interfere with study safety or efficacy.
You will not qualify if you...
- Receiving other investigational agents.
- Untreated or progressive brain metastases or leptomeningeal disease.
- Allergic reactions to similar compounds used in this study.
- Uncontrolled intercurrent illness.
- Psychiatric or social conditions limiting study compliance.
- Pregnant women.
- Breastfeeding women, due to potential risks to infants.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 16 weeks
Participants receive intratumoral HPV vaccinations during the 2nd and 4th weeks of radiation therapy, followed by additional vaccinations at weeks 8, 10, 12, and 16 after radiation. At each treatment visit, blood samples are taken, tumor cells are collected, and imiquimod cream is applied. Participants take metformin tablets twice daily and apply imiquimod cream at home three times per week for two weeks after each visit.
6 visits during and after radiation therapy
Follow-up
Duration - 2 years
Participants have follow-up PET/CT scans at week 20 and two years after treatment, with physical exams every three months for two years to monitor safety, side effects, and disease progression.
Follow-up exams every 3 months for 2 years plus 2 PET/CT scans
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
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Research Team
K
Keneshia K Lane, B.A.
K
Kathleen Pennington, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Case Report: Intra-Tumoral Vaccinations of Quadrivalent HPV-L1 Peptide Vaccine With Topical TLR-7 Agonist Following Recurrence: Complete Resolution of HPV-HR-Associated Gynecologic Squamous Cell Carcinomas in Two Patients.
Mark Reedy, Shirisha Jonnalagadda, Komaraiah Palle
https://pubmed.ncbi.nlm.nih.gov/34987310Synergy of Radiotherapy and a Cancer Vaccine for the Treatment of HPV-Associated Head and Neck Cancer.
Michele Mondini, Mevyn Nizard, Thi Tran...
https://pubmed.ncbi.nlm.nih.gov/25833837Comparative study of subcutaneous, intramuscular, and oral administration of bovine pathogenic Escherichia coli bacterial ghost vaccine in mice.
Jing Mu, Lei Lei, Yingce Zheng...
https://pubmed.ncbi.nlm.nih.gov/36451816Efficacy of metformin in combination with immune checkpoint inhibitors (anti-PD-1/anti-CTLA-4) in metastatic malignant melanoma.
Muhammad Zubair Afzal, Rima R Mercado, Keisuke Shirai
https://pubmed.ncbi.nlm.nih.gov/29966520Targeting of the tumor immune microenvironment by metformin.
Zihong Wu, Caidie Zhang, Masoud Najafi
https://pubmed.ncbi.nlm.nih.gov/34611852Metformin and cancer immunity.
Ruixia Ma, Bin Yi, Adam I Riker...
https://pubmed.ncbi.nlm.nih.gov/32868904Feasibility, safety and efficacy of human intra-tumoral immuno-therapy. Gustave Roussy's initial experience with its first 100 patients.
Lambros Tselikas, Antoine Dardenne, Thierry de Baere...
https://pubmed.ncbi.nlm.nih.gov/35724442The efficacy of topical imiquimod in high-grade cervical intraepithelial neoplasia: A systematic review and meta-analysis.
A J M van de Sande, M Kengsakul, M M Koeneman...
https://pubmed.ncbi.nlm.nih.gov/37350560Regression of human papillomavirus intraepithelial lesions is induced by MVA E2 therapeutic vaccine.
Ricardo Rosales, Mario López-Contreras, Carlos Rosales...
https://pubmed.ncbi.nlm.nih.gov/25275724