NCT05608369

Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 an approved therapy. 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 receive the study drug (Vorinostat) as a pre-treatment, followed by standard chemoradiation.

Detailed 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.

Conditions

• HPV-Related Squamous Cell Carcinoma
• Squamous Cell Carcinoma of the Oral Cavity
• Squamous Cell Carcinoma of the Larynx
• Squamous Cell Carcinoma of the Oropharynx
• Squamous Cell Carcinoma of the Hypopharynx

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin100 mg/m2 every 3 weeks or 40 mg/m2 weekly
RADIATION	Radiation therapy	Radiation therapy (70 Gy) for total of 7 weeks
DRUG	Vorinostat	Pre-treatment; 300 mg every other day and ends with the dose closest to the last fraction of radiation (total of 8 weeks)

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-08-01
• Completion: 2026-02-01
• First posted: 2022-11-08
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study