Clinical trial NCT05952934: Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Official title: A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Highlands Oncology Group, PA
name: NYU Langone Health
First posted: 2023-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.
Primary purpose: TREATMENT

Brief 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 80 subjects are eligible for injection.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of clinical efficacy
timeFrame: Through study completion, up to 2 years
Secondary outcomes:
measure: Assessment of adverse events
timeFrame: Regularly throughout the study, up to 2 years
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health
state: New York
Study officials:
affiliation: University of Arkansas
name: Omar Atiq
role: PRINCIPAL_INVESTIGATOR
References: