Decitabine + Standard Therapy for Head and Neck Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals, Investigational agents

Disqualifiers: Pregnancy, Immunocompromised, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Adam L. Holtzman, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with HPV-negative head and neck squamous cell cancers that can be surgically removed. Participants must have certain blood counts within normal ranges, no distant metastases, and an ECOG performance status of 0 or 1. They should not have had chemotherapy in the last 5 years for other conditions, be pregnant or nursing, HIV positive on antiretroviral therapy, or have any severe diseases that could interfere with the study.

Inclusion Criteria

Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)

I am fully active or restricted in physically strenuous activity but can do light work.

Platelet count ≥ 100,000/mm^3 (obtained ≤ 14 days prior to registration)

Exclusion Criteria

Nursing women

I had chemotherapy for a different condition within the last 5 years.

I am not on any experimental drugs for my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Patients receive decitabine intravenously over 1 hour once daily for 3 days and undergo standard of care surgery within 28 days of receiving decitabine

4 weeks

Adjuvant Treatment

Patients receive decitabine IV over 1 hour once daily for 3 days every 3 weeks during radiation therapy. Patients also undergo EBRT daily on 5 days per week for up to 5-35 treatments per standard of care. Concurrent chemotherapy may be administered per standard of care

Up to 15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Follow-up at 30 days, every 4-6 months for 2 years, then every 12 months

Treatment Details

Interventions

• Chemotherapy
• Decitabine
• External Beam Radiation Therapy
• Surgical Procedure

Trial Overview The trial tests decitabine combined with standard care (surgery, radiation/chemotherapy) to see if it's safe and effective against resectable HPV-negative head and neck cancers. Decitabine may make tumor cells more sensitive to treatment by stopping DNA production. The effectiveness of this combination will also be evaluated through questionnaires and biospecimen collection.

Participant Groups

Group I: Treatment (decitabine, surgery, radiation) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+