A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
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.
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 inject…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 and/or immunotherapy) within the 120 days prior to the screening visit * No Evidence of Disease (NED) based on clinical and 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 st…
Interventions
- Biological0.5 mL Candin®/injection
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
- OtherPlacebo: 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, PAFayetteville, Arkansas
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Highlands Oncology Group, PARogers, Arkansas
- Highlands Oncology Group, PASpringdale, Arkansas
- Perlmutter Cancer Center at NYU Langone HealthMineola, New York
- Perlmutter Cancer Center at NYU Langone HealthNew York, New York