Vorinostat + Chemoradiation for Head and Neck Cancer

(HPV Trial)

Overseen By Kyunghee Burkitt, DO, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: Pregnancy, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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.

Research Team

Kyunghee Burkitt, DO, PhD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive the study drug Vorinostat as a pre-treatment

2 weeks

Chemoradiation

Participants receive standard chemoradiation therapy in combination with Vorinostat

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 years

Treatment Details

Interventions

• Cisplatin
• Radiation therapy
• Vorinostat

Trial Overview The 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

Group I: Study drug + Standard of care chemoradiation Experimental Treatment 3 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:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Kyunghee Burkitt, DO, PhD

Lead Sponsor

Trials

1

Recruited

20+