Sunday, May 28, 2017 7:36:57 AM
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
Exclusion Criteria:
Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
Has metastatic disease (M1) Stage IV C
Has had prior radiation to the head and neck
Plan to be treated with cetuximab (Erbitux®)
Planned use of cisplatin as induction chemotherapy.
Has a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excised
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
Has incompletely healed sites of dental extractions
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)
Has untreated hypertension or has hypertension under treatment that meets protocol definitions.
Has active infectious disease undergoing systemic treatment excluding oral candidiasis
Has oral mucositis (of any severity) prior to initiation of radiation therapy
Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
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)
Use of any investigational agent within 30 days of randomization
Is pregnant or breastfeeding
Has known allergies or intolerance to brilacidin, cisplatin or carboplatin
Has inability to give informed consent or comply with study requirements
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.
Is unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study period
I was given that information....I don't know.
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