Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952934
• Other study ID #: 275695
• Status: Recruiting
• Phase: Phase 2
• Start date: February 12, 2024
• Est. completion date: February 1, 2029

Study information

• Verified date: April 2024
• Source: University of Arkansas
• Contact: Sorena Lo
• Phone: 501-686-8274
• Email: slo[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 68 subjects are eligible for injection.

Description:

This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Able to provide informed consent

• Male or female 18 years of age or older

• Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the previous 120 days.

• No Evidence of Disease (NED) based on clinical and/or radiographic evaluations

• Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

• Positive urine pregnancy test for women of childbearing potential

• Being pregnant or attempting to be pregnant with the period of study participation

• Women who are breast feeding or plan to breast feed within the period of study participation

• Patients who are allergic to Candin®

• If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Recurrence
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• 0.5 mL Candin®/injection
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Other:
• Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of clinical efficacy	Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint.	Through study completion, up to 2 years
Secondary	Assessment of adverse events	The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed.	Regularly throughout the study, up to 2 years