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Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

NCT05608369•Case Comprehensive Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have histologically or cytologically confirmed stage III or IV HPV negative squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, tumors is deemed to be either unresectable or locally advanced.
•Subjects must have received no prior therapies (chemotherapy or radiotherapy) for this disease
•Age \>18 years. Because the low occurrence of HNSCC in the pediatric population, children are excluded from this study
•ECOG Performance status ≤ 2
•Subjects must have normal organ and marrow function as defined below
•* Hemoglobin ≥ 9.0 g/dl (transfusion permitted)
•* Leukocytes ≥ 3,000/mcL
•* Absolute neutrophil count ≥ 1,500/mcL
•* Platelet count ≥ 100,000/mcL
•* Total bilirubin within normal institutional limits
+6 more criteria

Exclusion Criteria

•Eligibility for curative-intent surgery, previous chemotherapy.
•Subjects receiving any other investigational agents.
•Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat.
•Patients with previous exposure to vorinostat.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Pregnant women are excluded from this study because vorinostat may have potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, breastfeeding should be discontinued if the mother is treated with vorinostat. These potential risks may also apply to other agents used in this study.
•HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with vorinostat. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated. Also include whether HIV testing is required for this study, or only if a known diagnosis will be excluded.

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

June 1, 2025

Primary Completion Date

August 1, 2025

Completion Date

February 1, 2026

Last Updated

April 4, 2025

Conditions

HPV-Related Squamous Cell CarcinomaSquamous Cell Carcinoma of the Oral CavitySquamous Cell Carcinoma of the LarynxSquamous Cell Carcinoma of the OropharynxSquamous Cell Carcinoma of the Hypopharynx

Interventions

Cisplatin

DRUG

Radiation therapy

RADIATION

Vorinostat

DRUG

Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca

NCT04988074

HPV-Related Squamous Cell Carcinoma

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RECRUITINGPHASE1/PHASE2

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

NCT05639972

HPV-Associated Cervical CarcinomaHPV-Related Carcinoma+15 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC

Inclusion Criteria

Exclusion Criteria

Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab