Vorinostat + Chemoradiation for Head and Neck Cancer
(HPV Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKyunghee Burkitt, DO, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kyunghee Burkitt, DO, PhD

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with stage III or IV HPV negative squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx that can't be surgically removed. They must have no prior treatments for this cancer, an ECOG Performance status ≤ 2 (which means they are able to walk and do light activities), normal organ function, and agree to use contraception. Excluded are those with other serious illnesses, previous chemotherapy or vorinostat exposure, untreated brain metastases/CNS disease, HIV on antiretroviral therapy due to interaction risks.

Inclusion Criteria

- Total bilirubin within normal institutional limits.

- AST (SGOT) ≤ 2.5 X institutional upper limit of normal.

I can take care of myself but might not be able to do heavy physical work.

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Exclusion Criteria

Subjects receiving any other investigational agents.

I do not have any serious illnesses that would stop me from following the study's requirements.

I am eligible for surgery aimed at curing my condition and have had chemotherapy before.

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Treatment Details

Interventions

Cisplatin (Alkylating Agent)
Radiation therapy (Radiation)
Vorinostat (Histone Deacetylase Inhibitor)

Trial OverviewThe trial is testing Vorinostat in combination with standard chemoradiation treatment for head and neck cancer. Participants will either receive just the standard treatment (Group 1) or Vorinostat followed by the standard treatment (Group 2). The goal is to see if adding Vorinostat improves outcomes compared to only chemoradiation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Study drug + Standard of care chemoradiationExperimental Treatment3 Interventions

Participant will be pre-treated with study drug followed by continuation of standard chemoradiation

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: