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Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC — HPV  

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

Official title:
A Phase 2 Study of Vorinostat in Combination With Chemoradiation in Patients With Locally Advanced HPV Negative HNSCC

Clinical Trial Summary

The purpose of this study is to learn more about a drug called Vorinostat (an experimental drug) in combination with chemoradiation. The intention of this study is to learn if this drug is safe for the participants and whether this drug with chemoradiation is able to further increase the clinical efficacy of chemoradiation which is approved therapy for your tumor condition. The main question it aims to answer is: How may Vorinostat interact with standard chemotherapy and radiation therapy in head and neck cancer? Participants will be in either one of two study groups: Group 1 will receive standard chemoradiation, while group 2 will receive the study drug (Vorinostat) as a pre-treatment, followed by standard chemoradiation.

Clinical Trial Description

Histone deacetylase (HDAC) inhibitors have been shown to increase reverse resistance to cisplatin and radiation therapy. This phase 2 study comes after an already completed phase 1 study which examined tolerability of pan-HDAC inhibitor, Vorinostat, in combination with chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC). The study showed that Vorinostat in combination with concurrent chemoradiation therapy (CRT) is safe and estimated 5-year OS of HPV- patients is 77.8% which is considerably higher than the 5-year overall survival (OS) of 46.2% in HPV- HNSCC patients treated with standard concurrent chemoradiation. Based on this phase 1 study, the hypothesis is that Vorinostat, in combination with chemoradiation, will increase median progression-free survival compared to chemoradiation alone treatment in HPV-HNSCC. This study has two arms to compare cisplatin with radiation therapy for a total of seven weeks versus Vorinostat followed by combination with cisplatin and radiation therapy for a total of seven weeks. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • HPV-Related Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Cell Carcinoma of the Hypopharynx
  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of the Oropharynx
Clinical Trial Details
NCT number NCT05608369
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Kyunghee Burkitt, DO, PhD
Phone 1-800-641-2422
Email CTUReferral@UHhospitals.org
Status Not yet recruiting
Phase Phase 2
Start date June 1, 2024
Completion date February 1, 2026
View Details
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