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

ConditionsHuman Papillomavirus-Negative Neck Squamous Cell CarcinomaResectable Head and Neck Squamous Cell CarcinomaResectable Human Papillomavirus-Independent Head and Neck Mucosal Squamous Cell CarcinomaHPV-Negative Squamous Cell CarcinomaResectable Head and Neck Squamous-cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

REGISTRATION: Age ≥ 18 years

REGISTRATION: Histologic confirmation of HPV-negative, squamous cell carcinoma of the head and neck that is surgically resectable. HPV-status confirmation by p16, circulating tumor DNA or in-situ hybridization is only required for oropharyngeal primaries

Includes mucosal and non-mucosal subsites

Includes head and neck of unknown primary origin REGISTRATION: Measurable disease preoperatively, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or equivalent criteria

Disqualifiers

Pregnant women

Nursing women

Men or women who are of childbearing potential who are unwilling to employ adequate contraception

REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Chemotherapy

    Drug

    Given concurrent chemotherapy

  • Decitabine

    Drug

    Given IV

  • External Beam Radiation Therapy

    Radiation

    Undergo EBRT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Surgical Procedure

    Procedure/Surgery

    Undergo standard of care surgery

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Treatment (decitabine, surgery, radiation)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) of preoperative decitabine

MTD will be selected based on the rate of grade 4 toxicity and correlative methylation response data.

Time frame
From first dose of preoperative decitabine to the first dose of adjuvant decitabine
2

MTD of adjuvant decitabine

MTD will be selected based on the rate of grade 4 toxicity and correlative methylation response data.

Time frame
From first dose of adjuvant decitabine to 28 days after the end of treatment

Secondary outcomes

1

Incidence of acute (early onset) adverse events

Defined as toxicities which begin during the start of adjuvant therapy until 90 days post end of treatment. Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of acute AE will be recorded for each patient.

Time frame
Up to 90 days
2

Incidence of late onset adverse events

Defined as toxicities which begin from 91 days to two years post radiation therapy. Early onset toxicities can also be considered late toxicities if they persist for at least one day beyond the 90 days used to define late onset toxicities. Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of acute AE will be recorded for each patient.

Time frame
From 91 days to 2 years
3

Event-free survival

Defined as the interval from registration to last follow-up without an event, defined to include 1) recurrence of disease, 2) progression of disease, or 3) death.

Time frame
1 year, 2 years, 5 years
4

Overall survival

Defined as the interval from registration to last follow-up or death from any cause.

Time frame
1 year, 2 years, 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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