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Alkylating Agent

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

Phase 2
Waitlist Available
Research Sponsored by Kyunghee Burkitt, DO, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 2.5 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial studies if a drug (Vorinostat) combined with chemotherapy & radiation is safe & effective for head & neck cancer. Participants will receive either standard therapy (Group 1) or the study drug + standard therapy (Group 2).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Vorinostat may cause side effects like fatigue, digestive issues such as nausea and diarrhea, changes in blood counts leading to increased infection risk or bleeding problems. It might also affect liver function tests and could potentially harm a fetus if taken during pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 2.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 2.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival
Secondary study objectives
Objective response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
2014
Completed Phase 3
~1600
Cisplatin
2013
Completed Phase 3
~3120
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

Kyunghee Burkitt, DO, PhDLead Sponsor

Media Library

Cisplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05608369 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Study drug + Standard of care chemoradiation
Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05608369 — Phase 2
Cisplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608369 — Phase 2
~14 spots leftby Aug 2025
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