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Trial Title:
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
NCT ID:
NCT05952934
Condition:
Squamous Cell Carcinoma of Head and Neck
Conditions: Official terms:
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Recurrence
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a Phase II randomized, double-blind, placebo controlled, multi-site study of
Candin.
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
Each study site will received a separate randomization scheme, and the research pharmacy
at each site will implement and maintain randomization schedule.
Intervention:
Intervention type:
Biological
Intervention name:
0.5 mL Candin®/injection
Description:
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a
total of 7 injections.
Arm group label:
Candin vaccine
Intervention type:
Other
Intervention name:
Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Description:
Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7
injections.
Arm group label:
Placebo
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sorena Lo
Email:
SBLo@uams.edu
Contact backup:
Last name:
Aaron Holley
Email:
JAHolley@uams.edu
Start date:
February 12, 2024
Completion date:
February 1, 2029
Lead sponsor:
Agency:
University of Arkansas
Agency class:
Other
Source:
University of Arkansas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05952934
