RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-12
Study Completion:2029-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05952934

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent
  2. * Male or female 18 years of age or older
  3. * 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.
  4. * No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
  5. * Willing and able to comply with the requirements of the protocol
  1. * Positive urine pregnancy test for women of childbearing potential
  2. * Being pregnant or attempting to be pregnant with the period of study participation
  3. * Women who are breast feeding or plan to breast feed within the period of study participation
  4. * Patients who are allergic to Candin®
  5. * 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

Contacts and Locations

Study Contact

Madison Trujillo
CONTACT
501-686-8274
MTrujillo@uams.edu
Aaron Holley
CONTACT
501-686-8274
jaholley@uams.edu

Principal Investigator

Omar Atiq
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Omar Atiq, PRINCIPAL_INVESTIGATOR, University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2029-02-01

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2029-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma of Head and Neck