Decitabine for HPV-Negative Head and Neck Cancer
This study is testing a drug called decitabine along with standard treatments like surgery, radiation, and chemotherapy for head and neck cancers that are HPV-negative (not caused by human papillomavirus) and can be removed by surgery. Researchers want to find the safest and most effective dose of decitabine. Decitabine works by stopping cancer cells from making DNA, which may make chemotherapy more effective. You may be able to join if you are at least 18 years old and have this type of head and neck cancer. The study aims to see how well decitabine works to slow cancer progression and improve survival. The current status of this study is unclear, and it plans to enroll 32 participants.
- Study design
- This is a Phase 1 interventional study, meaning it tests a new treatment in a small group of people. It is a dose-escalation study, followed by a dose-expansion study.
- What's involved
- You will receive decitabine intravenously (IV) before surgery and during radiation therapy. You will also have blood samples collected and complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures the maximum tolerated dose of decitabine from the first dose until 28 days after the end of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06997094
Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~32 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Biospecimen CollectionChemotherapyDecitabineExternal Beam Radiation TherapyQuestionnaire AdministrationSurgical Procedure
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of preoperative decitabine
Measured over From first dose of preoperative decitabine to the first dose of adjuvant decitabine
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Adam L. Holtzman, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
REGISTRATION: Age ≥ 18 years
REGISTRATION: Histologic confirmation of HPV-negative, squamous cell carcinoma of the head and neck that is surgically resectable. HPV-status confirmation by p16, circulating tumor DNA or in-situ hybridization is only required for oropharyngeal primaries
Includes mucosal and non-mucosal subsites
Includes head and neck of unknown primary origin REGISTRATION: Measurable disease preoperatively, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or equivalent criteria
NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible
REGISTRATION: Absence of distant metastases on standard diagnostic work-up ≤ 16 weeks prior to registration. (chest computed tomography \[CT\] or positron emission tomography \[PET\]/CT)
REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
REGISTRATION: Hemoglobin ≤ 9.0 g/dL (obtained ≤ 14 days prior to registration)
REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration)
REGISTRATION: Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration)
REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)
REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy
REGISTRATION: Provide written informed consent
REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Patient received pre-operative decitabine dose
RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: The patient had study-specific surgery
RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Patient meets adjuvant radiation criteria based on investigator choice
Exclusion
REGISTRATION: Any of the following:
Pregnant women
Nursing women
Men or women who are of childbearing potential who are unwilling to employ adequate contraception
REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
REGISTRATION: Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Or psychiatric illness/social situations that would limit compliance with study requirements
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
REGISTRATION: Other active malignancy ≤ 5 years prior to registration
EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
REGISTRATION: Prior history of radiation therapy to the affected site
REGISTRATION: Prior systemic chemotherapy ≤ 5 years prior to registration for other diagnosis not related to study disease
REGISTRATION: Contraindication to radiation therapy as determined by the treating team
REGISTRATION: Contraindication to decitabine as determined by the treating team
RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Experienced a dose limiting toxicity (DLT) during pre-operative decitabine therapy
What this trial measures
- Maximum tolerated dose (MTD) of preoperative decitabineFrom first dose of preoperative decitabine to the first dose of adjuvant decitabine
MTD will be selected based on the rate of grade 4 toxicity and correlative methylation response data.
- MTD of adjuvant decitabineFrom first dose of adjuvant decitabine to 28 days after the end of treatment
MTD will be selected based on the rate of grade 4 toxicity and correlative methylation response data.