Actively Recruiting
Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer
Led by Mayo Clinic · Updated on 2026-01-26
24
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower progression and longer survival. Decitabine is also a clinically active demethylating agent, and may help make tumor cells more sensitive to radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. External beam radiation therapy (EBRT) is a type of radiation that uses a machine to aim high-energy rays at the tumor from outside the body. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving decitabine in combination with standard of care surgery, radiation and/or chemotherapy may be safe, tolerable, and/or effective in treating patients with surgically resectable HPV-negative head and neck squamous cell cancers.
CONDITIONS
Official Title
Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologic confirmation of HPV-negative squamous cell carcinoma of the head and neck that is surgically resectable
- Measurable disease before surgery as defined by RECIST 1.1 or equivalent
- No distant metastases based on chest CT or PET/CT within 16 weeks before registration
- Negative pregnancy test within 7 days before registration for women who can become pregnant
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Hemoglobin greater than or equal to 9.0 g/dL within 14 days before registration
- Absolute neutrophil count greater than or equal to 1500/mm3 within 14 days before registration
- Platelet count greater than or equal to 100,000/mm3 within 14 days before registration
- Total bilirubin less than or equal to 1.5 times upper limit of normal within 14 days before registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to 3 times upper limit of normal (or 5 times if liver involvement) within 14 days before registration
- Prothrombin time (PT)/INR/aPTT less than or equal to 1.5 times upper limit of normal within 14 days before registration or within target range if on anticoagulants
- Ability to provide written informed consent
- Ability to complete questionnaires alone or with help
- Willingness to provide mandatory blood and tissue samples for research
- Willingness to return to the enrolling institution for follow-up during active monitoring
- For adjuvant dose assignment: received preoperative decitabine, had study-specific surgery, and meet adjuvant radiation criteria
You will not qualify if you...
- Pregnant or nursing women
- Men or women of childbearing potential unwilling to use adequate contraception
- Serious systemic illnesses or other severe diseases making participation inappropriate or interfering with safety assessment
- Immunocompromised patients or HIV positive patients currently on antiretroviral therapy (unless no clinical immunocompromise)
- Failure to recover from acute effects of prior therapy except stable grade 1 peripheral neuropathy for at least 3 months
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Dyspnea at rest requiring continuous oxygen therapy
- Receiving other investigational agents for the primary cancer
- Other active cancers within 5 years except non-melanotic skin cancer or carcinoma in situ of the cervix
- History of myocardial infarction within 6 months or life-threatening ventricular arrhythmias requiring ongoing therapy
- Prior radiation therapy to the affected site
- Prior systemic chemotherapy within 5 years for other diagnoses unrelated to this cancer
- Contraindications to radiation therapy or decitabine as determined by the treating team
- For adjuvant dose assignment: experienced dose limiting toxicity during preoperative decitabine therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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