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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
HPV Trial 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.Check my eligibility
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.See study design
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.
HPV Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Objective response rate
HPV Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study drug + Standard of care chemoradiationExperimental Treatment3 Interventions
Participant will be pre-treated with study drug followed by continuation of standard chemoradiation
Group II: Standard of care chemoradiationActive Control2 Interventions
Participant will be treated with standard chemoradiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850
Vorinostat
2014
Completed Phase 3
~1600
Cisplatin
2013
Completed Phase 3
~1940
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: Standard of care chemoradiation
- Group 2: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the combination of Study drug and Standard of care chemoradiation been verified by the US Food and Drug Administration?
"The safety of this combination therapy was estimated to be 2, as it is still in Phase 2 and there are no efficacy data yet. However, the existing evidence suggests a good level of protection for participants."
Answered by AI
Are there still openings available for this research endeavor?
"Unfortunately, the clinical trial posted on December 1st 2022 is no longer recruiting. Nonetheless, there are currently 2675 other active studies seeking patients."
Answered by AI
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