Study on Vorinostat with Chemoradiation for Advanced HPV Negative Head and Neck Cancer

Sponsor: Kyunghee Burkitt, DO, PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05608369

Provider View

This clinical trial is exploring whether adding the experimental drug Vorinostat to standard chemotherapy and radiation therapy can improve treatment outcomes for patients with advanced HPV negative head and neck cancer.

Patient Parameters

Program Overview

The study aims to find out if Vorinostat, when used with standard chemotherapy and radiation therapy, is safe and can enhance the effectiveness of these treatments in patients with advanced head and neck cancer that is HPV negative. Participants will first receive Vorinostat, followed by the usual chemotherapy and radiation therapy.

Description

Vorinostat is a type of drug known as a histone deacetylase (HDAC) inhibitor, which may help make cancer cells more sensitive to chemotherapy and radiation. This study is in Phase 2, meaning it follows an earlier Phase 1 study that showed Vorinostat is safe to use with chemotherapy and radiation in patients with advanced head and neck cancer. The earlier study suggested that patients who received Vorinostat had better survival rates compared to those who only received standard treatment. This study will test if adding Vorinostat can help patients live longer without the cancer getting worse.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of stage III or IV HPV negative squamous cell carcinoma in the oral cavity, oropharynx, or hypopharynx that cannot be removed by surgery or is locally advanced.
  • Have not received any previous chemotherapy or radiation for this cancer.
  • Be over 18 years old.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Have normal organ and bone marrow function, as shown by specific blood tests.
  • Agree to use effective birth control during the study and for a period after the last dose of Vorinostat, as it may harm an unborn baby.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

  • Be eligible for surgery that could cure the cancer.
  • Have received any previous chemotherapy.
  • Be taking other experimental drugs.
  • Have untreated cancer that has spread to the brain or central nervous system.
  • Have a history of allergic reactions to similar drugs as Vorinostat.
  • Have previously taken Vorinostat.
  • Have uncontrolled health issues, such as ongoing infections, heart problems, or mental health conditions that could interfere with the study.
  • Be pregnant or breastfeeding, as Vorinostat may harm the baby.
  • Be HIV positive and on antiretroviral therapy, due to potential drug interactions and increased risk of infections.

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