Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

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.

Eligibility

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

Conditions2

Locations6 sites

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