Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
Condition: Head and Neck Neoplasms; Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: Brilacidin; Placebo
Intervention description: Oral Rinse used 3 times daily for 7 weeks
Intervention MeSH terms: Brilacidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral Mucositis; Brilacidin; Chemoradiation

Summary:

      Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation
      regimens used to treat cancer. This study examines the investigational drug brilacidin and
      its possible application in prevention of oral mucositis in patients undergoing
      chemoradiation for treatment of head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to read, understand and sign an informed consent form (ICF)

          2. Have recently diagnosed (within previous 6 months) pathologically confirmed,
             non-metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or
             supraglottic larynx that will be treated with CRT therapy as first line non-surgical
             treatment. Scans (CT, PET, and/or MRI) obtained within 120 days prior to consent for
             screening can be used to determine the subject's eligibility.

          3. Have a plan to receive a continuous course of conventional external beam irradiation
             delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0
             Gy to 2.2 Gy with a cumulative radiation dose ≥55 Gy and ≤72 Gy. Planned radiation
             treatment fields must include at least two oral sites (buccal mucosa, floor of mouth,
             ventral/lateral tongue, soft palate). [Note: the independent RTQA consultant must
             confirm that the planned radiation treatment meets the protocol criteria]

          4. Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly
             (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)

          5. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
             However, potential subjects with an ECOG of 3 may be enrolled provided their condition
             does not preclude performing the actions required by study participation (e.g.,
             opening medication bottles, swishing the oral rinse and spitting out, completing or
             participating in completion of daily diaries and FACT-H&N forms).

          6. Have adequate hematopoietic, hepatic, and renal function at a screening visit

          7. Urine or serum pregnancy test: negative for female patients of childbearing potential

          8. Agree to utilize medically accepted methods of birth control during study
             participation and for 90 days following the last treatment with study drug if a female
             subject is of childbearing potential or if a male subject has an opposite sex partner
             of child bearing potential.

          9. Males or females aged ≥18 years on day of consent.

        Exclusion Criteria:

          1. Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx,
             subglottic larynx or unknown primary tumor

          2. Has metastatic disease (M1) Stage IV C

          3. Has had prior radiation to the head and neck

          4. Plan to be treated with cetuximab (Erbitux®)

          5. Planned use of cisplatin as induction chemotherapy.

          6. Has a history of other malignant tumors within the last 5 years, except non melanoma
             skin cancer or in situ cervical carcinoma curatively excised

          7. Has had a major surgical procedure, other than for HNC, or significant traumatic
             injury within 4 weeks prior to the initiation of RT; anticipation of need for major
             surgical procedure during the course of the study

          8. Has incompletely healed sites of dental extractions

          9. Has an 12-lead ECG obtained at screening visit which shows medically significant
             abnormality(ies) (e.g. left bundle branch block, frequent premature ventricular
             contractions, QTc interval prolongation > 450 msec for males and > 470 msec for
             females)

         10. Has untreated hypertension or has hypertension under treatment that meets protocol
             definitions.

         11. Has active infectious disease undergoing systemic treatment excluding oral candidiasis

         12. Has oral mucositis (of any severity) prior to initiation of radiation therapy

         13. Has a diagnosis of an immunosuppressive illness or a condition requiring chronic
             immunosuppression

         14. Has known seropositivity for HIV or hepatitis C antibody, or known to be hepatitis B
             surface antigen positive (testing for these serologic markers is not required for
             enrollment in this protocol)

         15. Use of any investigational agent within 30 days of randomization

         16. Is pregnant or breastfeeding

         17. Has known allergies or intolerance to brilacidin, cisplatin or carboplatin

         18. Has inability to give informed consent or comply with study requirements

         19. Has any other condition or prior therapy that in the opinion of the Investigator would
             make the patient unsuitable for the study and/or unable to comply with requirements
             for follow-up visits.

         20. Is unwilling or unable to agree to swish and spit the study oral rinse three times per
             day during the study period