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Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC

NCT05608369 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-04-04

No results posted yet for this study

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.

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

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)

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Kyunghee Burkitt, DO, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-08-01
Completion
2026-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608369 on ClinicalTrials.gov