Is NCT06997094 recruiting in Jacksonville, FL?

Yes, NCT06997094 is currently recruiting participants at its Jacksonville, FL location. This human papillomavirus-negative neck squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Human Papillomavirus-Negative Neck Squamous Cell Carcinoma Clinical Trial in Jacksonville, FL

Q: How do I join the human papillomavirus-negative neck squamous cell carcinoma clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Human Papillomavirus-Negative Neck Squamous Cell Carcinoma Study in Jacksonville

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.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

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

NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible

REGISTRATION: Absence of distant metastases on standard diagnostic work-up ≤ 16 weeks prior to registration. (chest computed tomography \[CT\] or positron emission tomography \[PET\]/CT)

REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

REGISTRATION: Hemoglobin ≤ 9.0 g/dL (obtained ≤ 14 days prior to registration)

REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration)

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

REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)

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

REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy

REGISTRATION: Provide written informed consent

REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance

REGISTRATION: Willingness to provide mandatory blood specimens for correlative research

REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research

REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Patient received pre-operative decitabine dose

RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: The patient had study-specific surgery

RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Patient meets adjuvant radiation criteria based on investigator choice

Exclusion Criteria

REGISTRATION: Any of the following:

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

REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy

NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

REGISTRATION: Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment

EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment

REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection

Symptomatic congestive heart failure

Unstable angina pectoris

Cardiac arrhythmia

Or psychiatric illness/social situations that would limit compliance with study requirements

Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy

REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

REGISTRATION: Other active malignancy ≤ 5 years prior to registration

EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix

NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer

REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

REGISTRATION: Prior history of radiation therapy to the affected site

REGISTRATION: Prior systemic chemotherapy ≤ 5 years prior to registration for other diagnosis not related to study disease

REGISTRATION: Contraindication to radiation therapy as determined by the treating team

REGISTRATION: Contraindication to decitabine as determined by the treating team

RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Experienced a dose limiting toxicity (DLT) during pre-operative decitabine therapy

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT06997094) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Human Papillomavirus-Negative Neck Squamous Cell Carcinoma Treatment Options in Jacksonville, FL

If you're searching for human papillomavirus-negative neck squamous cell carcinoma treatment options in Jacksonville, FL, this clinical trial (NCT06997094) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced human papillomavirus-negative neck squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all human papillomavirus-negative neck squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Human Papillomavirus-Negative Neck Squamous Cell Carcinoma Clinical Trial in Jacksonville, FL

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