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Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Sponsor: University of Arkansas
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.
Official title: A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-02-12
Completion Date
2031-07-31
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
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.
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 (6)
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Highlands Oncology Group, PA
Springdale, Arkansas, United States
Perlmutter Cancer Center at NYU Langone Health
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States