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Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (Brilacidin)

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ClinicalTrials.gov Identifier: NCT02324335
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Innovation Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Mucositis Drug: Brilacidin Other: Placebo Phase 2

Detailed Description:
This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phase 2 Study to Evaluate the Efficacy & Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients With Head & Neck Cancer Receiving Chemoradiation
Actual Study Start Date : August 14, 2014
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : November 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Comparator Oral Rinse
Water for Injection
Other: Placebo
Other Name: Water for Injection

Active Comparator: Active Compator Oral Rinse
Brilacidin 3 mg/mL in Water for Injection
Drug: Brilacidin
Oral Rinse used 3 times daily for 7 weeks
Other Name: PMX30063




Primary Outcome Measures :
  1. Incidence of severe oral mucositis (WHO Grade ≥3) [ Time Frame: 7 weeks ]
    Incidence of severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 11 weeks ]
    Reporting of Adverse Events and severity of adverse events


Secondary Outcome Measures :
  1. Duration of severe oral mucositis (WHO Grade ≥3) [initial instance duration] [ Time Frame: 11 weeks ]
    Duration of severe oral mucositis (WHO Grade ≥3), from initial WHO Grade ≥3 during radiation therapy to the first WHO Grade 2 or lower

  2. Duration of severe oral mucositis (WHO Grade ≥3) [overall duration] [ Time Frame: 11 weeks ]
    Duration of severe oral mucositis (WHO Grade ≥3), from initial WHO Grade ≥3 during radiation therapy to the last WHO Grade ≥3

  3. Incidence of severe oral mucositis (WHO Grade ≥3) by cumulative radiation dose [ Time Frame: 7 weeks ]
    Incidence of severe oral mucositis (WHO Grade ≥3) at cumulative fractions of radiation therapy

  4. Time to onset of severe oral mucositis (WHO Grade ≥3) [ Time Frame: 7 weeks ]
    Time to onset (in days, and in cumulative radiation dose) of severe oral mucositis (WHO Grade ≥3)

  5. Exploratory: Total number of days of severe oral mucositis (WHO Grade ≥3) [ Time Frame: 11 weeks ]
    Total number of days (per subject) of severe oral mucositis (WHO Grade ≥3)

  6. Exploratory: Incidence of ulcerative oral mucositis (WHO Grade ≥2) by cumulative radiation dose [ Time Frame: 7 weeks ]
    Incidence of ulcerative oral mucositis (WHO Grade ≥2) by cumulative fractions of radiation therapy

  7. Exploratory: Time to onset of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 7 weeks ]
    Time to onset (in days, and in cumulative radiation dose) of ulcerative oral mucositis (WHO Grade ≥2)

  8. Exploratory: Duration of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 11 weeks ]
    Duration of ulcerative oral mucositis (WHO Grade ≥2)

  9. Exploratory: Total number of days of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 11 weeks ]
    Total number of days (per subject) of ulcerative oral mucositis (WHO Grade ≥2)

  10. Exploratory: Area under the oral mucositis-severity versus time curves [ Time Frame: 11 weeks ]
    Area under the oral mucositis-severity versus time curves

  11. Exploratory: Incidence of Mouth and Throat Soreness [ Time Frame: 11 weeks ]
    Mouth and throat soreness will be assessed daily using Oral Mucositis Daily Questionnaire (OMDQ) Question #2

  12. Exploratory: Quality of Life (QOL) Assessment [ Time Frame: 11 weeks ]
    Quality of Life assessed weekly (FACT-H&N)

  13. Exploratory: Incidence of Analgesic Concumption [ Time Frame: 11 weeks ]
    Analgesic consumption for pain due to OM

  14. Exploratory: Incidence of Gastrostomy tube (G-tube) use [ Time Frame: 11 weeks ]
    Use of gastrostomy tube (G-tube) for nutritional support due to OM

  15. Exploratory: Incidence of Unplanned Office Visits [ Time Frame: 11 weeks ]
    Number of Unplanned Office visits, emergency department visits, and hospital admissions due to OM

  16. Exploratory: Incidence of Unplanned Delays in Chemotherapy and/or RT Schedule [ Time Frame: 11 weeks ]
    Incidence of Unplanned Delays in Chemotherapy and/or RT Schedule due to OM



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324335


Locations
United States, Arizona
Gilbert, Arizona, United States, 85234
United States, Florida
Lakeland, Florida, United States, 33805
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Kentucky
Louisville, Kentucky, United States, 40207
United States, Louisiana
Shreveport, Louisiana, United States, 71103
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Cheektowaga, New York, United States, 14225
Poughkeepsie, New York, United States, 11794
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11794
United States, Ohio
Cleveland, Ohio, United States, 44106
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Innovation Pharmaceuticals, Inc.
Investigators
Study Director: W. James Alexander, MD Cellceutix Corporation

Responsible Party: Innovation Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02324335     History of Changes
Other Study ID Numbers: CTIX-BRI-205
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Innovation Pharmaceuticals, Inc.:
Oral Mucositis
Brilacidin
Chemoradiation

Additional relevant MeSH terms:
Mucositis
Stomatitis
Head and Neck Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Neoplasms