Actively Recruiting
Phase I Study of Decitabine Dose-Tolerance Combined With Surgery, Radiation, and Chemotherapy for Surgically Resectable HPV-Negative Head and Neck Cancer
Led by Mayo Clinic · Updated on 2026-01-26
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of decitabine combined with standard surgery, radiation, and/or chemotherapy for treating patients with surgically removable HPV-negative head and neck squamous cell cancers. This phase I trial explores how decitabine, which may help cancer cells respond better to chemotherapy and radiation, works alongside standard treatments to manage this type of cancer. The study involves two main treatment phases. In the preoperative phase, patients receive decitabine intravenously once daily for three days before undergoing surgery within 28 days. In the adjuvant phase, patients receive decitabine intravenously once daily for three days every three weeks alongside daily external beam radiation therapy for up to 5-35 treatments. Concurrent chemotherapy may also be given as part of standard care. Blood samples are collected throughout the study for research purposes. Participants will be monitored for maximum tolerated doses of decitabine during both treatment phases, acute and late side effects, survival outcomes, and quality of life. Follow-up visits occur 30 days after treatment, every 4-6 months for two years, then yearly for up to five years. Assessments include questionnaires, imaging, and laboratory tests to evaluate treatment effects and patient well-being over time.
CONDITIONS
Brief 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 can be surgically removed
- Measurable disease before surgery as defined by RECIST 1.1 or equivalent criteria
- No distant metastases within 16 weeks before registration as shown by chest CT or PET/CT
- Negative pregnancy test within 7 days before registration for women of childbearing potential
- ECOG performance status of 0 or 1
- Hemoglobin level above 9.0 g/dL within 14 days before registration
- Absolute neutrophil count of at least 1500/mm3 within 14 days before registration
- Platelet count of at least 100,000/mm3 within 14 days before registration
- Total bilirubin no more than 1.5 times the upper limit of normal within 14 days before registration
- ALT and AST no more than 3 times the upper limit of normal (or 5 times if liver involved) within 14 days before registration
- Prothrombin time/INR/aPTT no more than 1.5 times the upper limit of normal or within therapeutic range if on anticoagulants within 14 days before registration
- Ability to provide written informed consent
- Ability to complete questionnaires independently or with assistance
- Willingness to provide mandatory blood and tissue samples for research
- Willingness to return to the study site for follow-up visits during active monitoring
- Received preoperative decitabine dose for adjuvant dose assignment
- Completed study-specific surgery for adjuvant dose assignment
- Meet adjuvant radiation criteria based on investigator choice
You will not qualify if you...
- Pregnant or nursing women
- Men or women of childbearing potential unwilling to use adequate contraception
- Severe systemic illnesses or other serious diseases interfering with study safety or assessments
- Immunocompromised patients or HIV-positive patients on antiretroviral therapy
- Patients not recovered from acute effects of prior therapy except stable grade 1 peripheral neuropathy
- Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study 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 cervical carcinoma in situ
- History of myocardial infarction within 6 months or life-threatening arrhythmias requiring ongoing treatment
- Prior radiation therapy to the affected site
- Prior systemic chemotherapy within 5 years for other diagnoses
- Contraindications to radiation therapy or decitabine as determined by treating team
- Experienced dose limiting toxicity during preoperative decitabine therapy for adjuvant dose assignment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive decitabine intravenously once daily for 3 days before undergoing standard of care surgery within 28 days.
3 daily visits for decitabine administration and 1 surgery visit
Duration - Up to approximately 5 to 7 weeks
Participants receive decitabine intravenously once daily for 3 days every 3 weeks during radiation therapy, which occurs 5 days per week for up to 5 to 7 weeks. Participants may also receive concurrent chemotherapy as part of standard care.
Multiple visits during radiation therapy: daily radiation on 5 days per week with decitabine given 3 days every 3 weeks
Duration - Up to 5 years
After completing study treatment, participants are followed up at 30 days, every 4 to 6 months for 2 years, and then every 12 months for up to 5 years for long-term monitoring.
1 visit at 30 days, then visits every 4 to 6 months for 2 years, then annual visits
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
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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