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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT05952934
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 0.5 mL Candin®/injection — BIOLOGICAL
    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
    Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Assessment of clinical efficacy [ Time Frame: Through study completion, up to 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group, PAFayettevilleArkansas72762
Jennifer Worth
[email protected]
479-872-8130
Amy Purcell
[email protected]
479-872-8130
Joseph T Beck, MD, FACP (PRINCIPAL_INVESTIGATOR)
University of Arkansas for Medical SciencesLittle RockArkansas72205
Madison Trujillo
[email protected]
Aaron Holley
[email protected]
Highlands Oncology Group, PARogersArkansas75758
Jennifer Worth
[email protected]
479-872-8130
Amy Purcell
[email protected]
479-872-8130
Joseph T Beck, MD, FACP (PRINCIPAL_INVESTIGATOR)
Highlands Oncology Group, PASpringdaleArkansas72762
Jennifer Worth
[email protected]
479-872-8130
Amy Purcell
[email protected]
479-872-8130
Joseph T Beck, MD, FACP (PRINCIPAL_INVESTIGATOR)
Perlmutter Cancer Center at NYU Langone HealthMineolaNew York11501
Zujun Li, MD
[email protected]
212-731-6465
NYU Langone Health
[email protected]
Zujun Li, MD (PRINCIPAL_INVESTIGATOR)
Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Zujun Li, MD
[email protected]
212-731-6465
NYU Langone Health
[email protected]
Zujun Li, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fayetteville, AR

By research site
Highlands Oncology Group, PA· Fayetteville, ARUniversity of Arkansas for Medical Sciences· Little Rock, ARHighlands Oncology Group, PA· Rogers, ARHighlands Oncology Group, PA· Springdale, ARPerlmutter Cancer Center at NYU Langone Health· Mineola, NYPerlmutter Cancer Center at NYU Langone Health· New York, NY

Related Studies