NisinZ® P for Oral Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Antibiotics, Anticancer therapy
Disqualifiers: HPV positive, Oropharyngeal cancer, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a study of oral nisin administration in patients with OSCC who are undergoing complete surgical resection surgery with or without adjuvant radiation/chemoradiation as part of their routine care at the University of California, San Francisco (UCSF).
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on long-term antibiotics or systemic anticancer therapy, you may need to discuss this with the study team.
Eligibility Criteria
This trial is for adults with non-metastatic oral cavity squamous cell carcinoma (OSCC) who are undergoing surgery at UCSF. Participants must have confirmed OSCC, be able to consent, and not have distant metastases or a history of certain other cancers. They should not have untreated major dental issues or allergies to nisin.Inclusion Criteria
I have at least two of my own teeth.
My surgery and follow-up treatment will follow my usual care plan, not changed by this study.
I am 18 years old or older.
+5 more
Exclusion Criteria
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
I am undergoing major dental surgery as part of my long-term treatment.
Individuals with a known history of hypersensitivity reactions or oral allergies to nisin, any of its excipients, or any related food preservatives
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Phase I
Participants receive oral nisin once daily starting two weeks before planned OSCC resection surgery and continue for 6 additional months post-surgery. Nisin is withheld during surgery.
6 months
Regular visits for monitoring adverse events and dose adjustments
Treatment Phase IIa
Participants continue receiving oral nisin at the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for 6 months post-surgery.
6 months
Regular visits for monitoring treatment completion and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of periodontal conditions and adverse events.
12 months
Periodic follow-up visits
Participant Groups
The study tests the effects of an oral compound called NisinZ® P in patients with OSCC alongside their standard surgical treatment. It aims to see if NisinZ® P can improve outcomes when used as part of routine care that may include radiation/chemoradiation post-surgery.
2Treatment groups
Experimental Treatment
Group I: Phase IIa, Dose Expansion (MTD/RP2D)Experimental Treatment2 Interventions
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.
Group II: Phase I, Dose Finding - Starting Dose (20,000 mg)Experimental Treatment2 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
University of California, Los AngelesCollaborator
National Cancer Institute (NCI)Collaborator
References
Nisin ZP, a Bacteriocin and Food Preservative, Inhibits Head and Neck Cancer Tumorigenesis and Prolongs Survival. [2022]The use of small antimicrobial peptides or bacteriocins, like nisin, to treat cancer is a new approach that holds great promise. Nisin exemplifies this new approach because it has been used safely in humans for many years as a food preservative, and recent laboratory studies support its anti-tumor potential in head and neck cancer. Previously, we showed that nisin (2.5%, low content) has antitumor potential in head and neck squamous cell carcinoma (HNSCC) in vitro and in vivo. The current studies explored a naturally occurring variant of nisin (nisin ZP; 95%, high content) for its antitumor effects in vitro and in vivo. Nisin ZP induced the greatest level of apoptosis in HNSCC cells compared to low content nisin. HNSCC cells treated with increasing concentrations of nisin ZP exhibited increasing levels of apoptosis and decreasing levels of cell proliferation, clonogenic capacity, and sphere formation. Nisin ZP induced apoptosis through a calpain-dependent pathway in HNSCC cells but not in human oral keratinocytes. Nisin ZP also induced apoptosis dose-dependently in human umbilical vein endothelial cells (HUVEC) with concomitant decreases in vascular sprout formation in vitro and reduced intratumoral microvessel density in vivo. Nisin ZP reduced tumorigenesis in vivo and long-term treatment with nisin ZP extended survival. In addition, nisin treated mice exhibited normal organ histology with no evidence of inflammation, fibrosis or necrosis. In summary, nisin ZP exhibits greater antitumor effects than low content nisin, and thus has the potential to serve as a novel therapeutic for HNSCC.
Predictors of adverse events after neck dissection: An analysis of the 2006-2011 National Surgical Quality Improvement Program (NSQIP) Database. [2019]While neck dissection is an important primary and adjunctive procedure in the treatment of head and neck cancer, there is a paucity of studies evaluating outcomes. A retrospective review of the National Surgical Quality Improvement Program (NSQIP) database was performed to identify factors associated with adverse events (AEs) in patients undergoing neck dissection. A total of 619 patients were identified, using CPT codes specific to neck dissection. Of the 619 patients undergoing neck dissection, 142 (22.9%) experienced an AE within 30 days of the surgical procedure. Risk factors on multivariate regression analysis associated with increased AEs included dyspnea (odds ratio [OR] 2.57; 95% confidence interval [CI] 1.06 to 6.22; p = 0.037), previous cardiac surgery (OR 3.38; 95% CI 1.08 to 10.52; p = 0.036), increasing anesthesia time (OR 1.005; 95% CI 1 to 1.009; p = 0.036), and increasing total work relative value units (OR 1.09; CI 1.04 to 1.13; p
[Development of a risk map in an oral and maxillofacial surgical unit]. [2020]the main aim of this study was to develop and implement a risk map in the Oral and Maxillofacial Surgery Service of the University Hospital «Virgen de las Nieves» of Granada to minimize the incidence of adverse effects (AE).
Classification of intraoperative adverse events in visceral surgery. [2023]Intraoperative adverse events (iAEs) are frequent in visceral surgery, but severity and related postoperative outcome are poorly investigated. A novel classification of intraoperative adverse events, ClassIntra, includes surgical and anesthesiologic intraoperative adverse events using 5 severity grades and showed a high criterion and construct validity across all surgical disciplines. ClassIntra was studied for reproducibility in a prespecified group of patients undergoing visceral surgery.
Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. [2022]To prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events.