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

ConditionSquamous Cell Carcinoma of Head and Neck

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

0.5 mL Candin®/injection
Biological/Vaccine
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)
Other intervention
Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Candin vaccineActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Assessment of clinical efficacy

Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint.

Time frame

Through study completion, up to 2 years

Secondary outcomes

Assessment of adverse events

The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed.

Time frame

Regularly throughout the study, up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

Highlands Oncology Group, PA

Collaborator

NYU Langone Health