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

NCT06997094 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-26

No results posted yet for this study

Summary

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

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Chemotherapy

Given concurrent chemotherapy

DRUG

Decitabine

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Surgical Procedure

Undergo standard of care surgery

Sponsors & Collaborators

Principal Investigators

  • Adam L. Holtzman, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-23
Primary Completion
2027-11-08
Completion
2027-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997094 on ClinicalTrials.gov