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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Highlands Oncology Group, PA
RECRUITING
Fayetteville
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Highlands Oncology Group, PA
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
New York
Perlmutter Cancer Center at NYU Langone Health
RECRUITING
Mineola
Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Madison Trujillo
MTrujillo@uams.edu
501-686-8274
Backup
Aaron Holley
jaholley@uams.edu
501-686-8274
Time Frame
Start Date: 2024-02-12
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Candin vaccine
Seven Candida (Candin). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given.
Placebo_comparator: Placebo
Seven placebo injections (sterile 0.9% Normal Saline). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given.
Sponsors
Collaborators: NYU Langone Health, Highlands Oncology Group, PA
Leads: University of Arkansas

This content was sourced from clinicaltrials.gov