Study on HPV Vaccine, Imiquimod, and Metformin Combination for Treating HPV-Related Cancers

Sponsor: Baylor College of Medicine

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06686043

Provider View

This clinical trial is testing whether adding new treatments to standard therapy can help the immune system fight cancers caused by the Human Papillomavirus (HPV). The study will also check the safety of these treatments.

Patient Parameters

Program Overview

The aim of this study is to see if combining the HPV vaccine with other treatments like imiquimod cream and metformin pills can help the body fight HPV-related cancers more effectively. Participants will receive these treatments alongside their regular cancer therapy to see if the combination works better than standard treatment alone. The study will also monitor any side effects that may occur.

Description

In this trial, researchers are exploring whether adding the HPV vaccine, imiquimod cream, and metformin pills to standard cancer treatments can improve outcomes for patients with advanced cervical, vaginal, or vulvar cancer. The main goal is to see if this approach can help patients live longer without the cancer getting worse. Participants will receive the HPV vaccine during and after radiation therapy, apply imiquimod cream, and take metformin pills. The study will also track how these treatments affect the immune system and any side effects that occur. Blood samples and tumor cell samples will be collected to monitor changes in the immune system throughout the trial.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced cervical, vaginal, or vulvar cancer that cannot be treated with surgery alone.
  • Have measurable cancer that can be tracked with scans.
  • Be 18 years or older.
  • Have good overall health and organ function based on specific medical tests.
  • Be able to take part in chemoradiation treatment.
  • Women must not be pregnant and must agree to use effective birth control during the study.
  • Agree not to donate blood during the study and for 90 days after the last treatment.
  • Be able to understand and agree to the study procedures by signing a consent form.
  • Have a recent CT or PET-CT scan.
  • Be newly diagnosed with cancer.
  • Have a tumor that can be accessed for injection.
  • If HIV positive, have a stable condition with treatment.
  • If previously treated for hepatitis B or C, have the infection under control.
  • If treated for brain metastases, have no signs of progression.

Exclusion Criteria

  • Currently taking other experimental treatments.
  • Have untreated or worsening brain metastases.
  • Have allergies to similar treatments used in the study.
  • Have uncontrolled medical conditions.
  • Have mental health or social issues that would prevent following the study requirements.
  • Pregnant women are excluded due to potential risks to the baby.

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