Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06997094
Phase
PHASE1
Status
Recruiting
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Conditions

  • HPV-Negative Squamous Cell Carcinoma
  • Human Papillomavirus-Negative Neck Squamous Cell Carcinoma
  • Resectable Head and Neck Squamous Cell Carcinoma
  • Resectable Head and Neck Squamous-cell Carcinoma
  • Resectable Human Papillomavirus-Independent Head and Neck Mucosal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Chemotherapy — DRUG
    Given concurrent chemotherapy
  • Decitabine — DRUG
    Given IV
  • External Beam Radiation Therapy — RADIATION
    Undergo EBRT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Surgical Procedure — PROCEDURE
    Undergo standard of care surgery

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Jan 2026
Primary completion
Nov 8, 2027
Completion
Nov 8, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (decitabine, surgery, radiation)
    PREOPERATIVE PHASE: Patients receive decitabine IV over 1 hour QD for 3 days and undergo standard of care surgery within 28 days of receiving decitabine. ADJUVANT TREATMENT: Patients receive decitabine IV over 1 hour QD for 3 days every 3 weeks during radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT QD on 5 days per week for up to 5-35 treatments per standard of care. Patients may receive concurrent chemotherapy of choice per standard of care. Patients also undergo blood sample collection throughout the study.

Primary Outcome Measure

Maximum tolerated dose (MTD) of preoperative decitabine [ Time Frame: From first dose of preoperative decitabine to the first dose of adjuvant decitabine ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Adam L. Holtzman, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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