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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 2.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 2.5 years)
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.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.I have been treated with vorinostat before.I am not HIV-positive or not on antiretroviral therapy.I do not have untreated brain metastases or CNS disease.I am not pregnant or breastfeeding.I have not received any treatments like chemotherapy or radiotherapy for my condition.I am older than 18 years.I agree to use birth control during and after the study.My organ and bone marrow functions are normal.I do not have any severe illnesses that could interfere with the study.My cancer is stage III or IV, HPV negative, and affects my mouth or throat.
Research Study Groups:
This trial has the following groups:- Group 1: Study drug + Standard of care chemoradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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