RecruitingPhase 2NCT05952934

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

A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Sponsor

University of Arkansas

Enrollment

100 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a therapeutic vaccine made from Candida (a common fungal organism) can help prevent head and neck cancer from coming back after curative treatment. Researchers believe this vaccine may boost the immune system's ability to detect and destroy any remaining cancer cells. **You may be eligible if...** - You are 18 or older - You have squamous cell carcinoma of the head and neck - You have completed curative treatment (surgery, radiation, and/or chemotherapy) within the past 120 days - Your cancer shows no evidence of disease after treatment **You may NOT be eligible if...** - You are pregnant, trying to become pregnant, or breastfeeding during the study - You have a known allergy to Candin® (the vaccine used in this study) - Your doctor believes participation is not in your best interest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, 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

View Full Details on ClinicalTrials.gov

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NCT05952934

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