Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT05608369
Phase
PHASE2
Status
Withdrawn

Conditions

  • HPV-Related Squamous Cell Carcinoma
  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Apr 2025
Primary completion
Aug 1, 2025
Completion
Feb 1, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study drug + Standard of care chemoradiation
    Participant will be pre-treated with study drug followed by continuation of standard chemoradiation

Primary Outcome Measure

Progression free survival [ Time Frame: Through completion of follow-up (estimated to be 2.5 years) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-

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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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