Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)
ConditionOral Cavity Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with a suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) who are planning to undergo a diagnostic biopsy. Note: Subsequent documentation from the medical record (e.g., from the diagnostic biopsy pathology report) of histological or cytological confirmation of OSCC is required prior to enrollment and treatment on study. Participants who do not have a histological/cytological confirmation of OSCC, or who are unable to provide sufficient volume of biopsy tissue for research, will not be eligible to enroll in the study.
OSCC mass must be >= 2cm in size.
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).
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
NisinZ® P
DrugNisinZ® P is an ultrapure Nisin Z concentrate produced by fermentation using the bacterium Lactococcus lactis obtained from sauerkraut
Surgery (non-interventional, standard of care)
Procedure/SurgerySurgical removal of tumor as part of standard of care treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Phase I, Dose Finding - Starting Dose (20,000 mg)Experimental treatment 2 interventions
Group B: Phase IIa, Dose Expansion (MTD/RP2D)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of participants with dose limiting toxicities (DLT) (Phase I)
Dose-limiting toxicities (DLTs) are defined in Section 5.2.3. DLT determination will assess adverse events (AEs) graded according to CTCAE v5.0, including findings on physical exam, vital signs, laboratory testing, and spontaneous reports of AEs reported to the investigator by participants. DLT data will be summarized as proportions of participants experiencing DLTs per cohort
Time frame
Up to 6 months2
Maximum Tolerated Dose / Recommended Phase II Dose (RP2D) (Phase I)
The maximum tolerated dose (MTD) is the highest dose at which no more than one instance of DLT is observed among 6 participants treated. The MTD from Phase I will be the recommended Phase IIa dose (RP2D) for use in Phase IIa.
Time frame
Up to 4 weeks3
Proportion of participants completing treatment (Phase II)
The treatment completion rate is defined as the proportion of participants allocated to receive nisin at the RP2D and who complete the full nisin regimen, missing fewer than 30% of doses over the course of the regimen. A full nisin regimen is defined as starting nisin 2 weeks before surgery and continuing for 6 months after surgery.
Time frame
Up to 6 monthsSecondary outcomes
1
Incidence of Treatment-emergent adverse events (AE)
Safety will be assessed by monitoring adverse events (AEs), including Grade \>=3 intraoral mucositis. AEs will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. AEs will be evaluated up to 60 days after treatment discontinuation.
Time frame
Up to 8 months2
Mean change in dimensional measurement of ulcerations over time
Mean change in cross-sectional, dimensional measurement of tumors/ulcerations from baseline to post-surgery will be measured with calipers during a dental exam and reported by cohort.
Time frame
Up to 6 months3
Proportion of participants with changes in periodontal pocket depth
Clinical changes in periodontal pocket depth on dental examination over the study period will be assessed according to the American Academy of Periodontology grading system.
Time frame
Up to 6 months4
Proportion of participants with changes in periodontal clinical detachment loss
Clinical changes in clinical detachment loss on dental examination over the study period will be assessed according to the American Academy of Periodontology grading system.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
University of California, Los Angeles
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov