Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)
Oral Cavity Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Oral Cavity Squamous Cell Carcinoma focused on measuring Oral Microbiome, Natural Food Preservative
Eligibility Criteria
Inclusion Criteria: Histological or cytological confirmation of oral cavity squamous cell carcinoma (OSCC). Non-metastatic OSCC (no distant metastases allowed; metastasis to the neck is eligible). Participants must be planning for a complete OSCC surgical resection, with or without adjuvant radiation/chemoradiation, at UCSF, as part of their routine treatment plan. Surgical resection and adjuvant treatment will be according to the participants routine or standard of care treatment plan and will not be dictated by the study (non-interventional). Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%). Participants must be dentate (retaining at least two teeth). Teeth are required for plaque sample collection for correlative studies. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Individuals with a history of a known positive human papillomavirus deoxyribonucleic acid ((HPV DNA) test (P16-positive is permitted if HPV DNA test is negative). Individuals with a history of or concurrent oropharyngeal, laryngeal, or hypopharyngeal cancers (other than OSCC). Individuals with any other prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible. Individuals with ongoing uncorrected oral pathology, which in the opinion of the investigator could interfere with the safety or endpoints of this study or could be exacerbated during the course of study participation, if left untreated. These conditions may be discussed with the study PI to determine eligibility. Current and ongoing long-term dental treatment requiring major surgery; Untreated carious lesions, severe oral infections, or known defective restorations; Other suspicious uncorrected oral pathology. Individuals with a known history of hypersensitivity reactions or oral allergies to nisin, any of its excipients, or any related food preservatives. Individuals with complete inability to absorb nutrients via gastrointestinal tract due to major medical disorder or history of gastrointestinal surgical removal. Individuals who have received extended (>4 weeks) antibiotic therapy within 1 month of the baseline visit or who currently require continuous antibiotic prophylaxis at the time of enrollment. Individuals who require treatment with a systemic anticancer therapy prior to enrollment. Concurrent systemic anticancer therapy or chemoradiation is permitted after enrollment. Individuals currently receiving any other investigational agent or using an investigational device intended as anticancer therapy. Individuals with ongoing Grade 2 events that are not clinically stable or ongoing >= Grade 3 events (CTCAE v5.0 grading). Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities, interfere with participant safety, or study endpoints.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase I, Dose Finding - Starting Dose (20,000 mg)
Phase IIa, Dose Expansion (MTD/RP2D)
Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The starting dose level, with dose modification permitted for toxicity management or intolerability will be 20,000 mg (2 x 10 g bottles) per day.
Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The dose level will be determined by the outcomes in Phase 1 (RP2D), with dose modification permitted for toxicity management or intolerability.