Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Arkansas
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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®
Trial design
Treatments tested in this trial
- 0.5 mL Candin®/injection
- Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Arkansas
Lead sponsor
Highlands Oncology Group, PA
Collaborator
NYU Langone Health
Collaborator
Source ClinicalTrials.gov