Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.5 mL Candin®/injection, Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline).
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of Head and Neck. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Overview
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.
Detailed description
This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.
Interventions
- Biological 0.5 mL Candin®/injection
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections. - Other Placebo: 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.
Primary outcome measures
- Assessment of clinical efficacy [Time frame: Through study completion, up to 2 years]
Secondary outcome measures (1)
- Assessment of adverse events [Time frame: Regularly throughout the study, up to 2 years]
Eligibility criteria
Inclusion criteria
- 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
- Willing and able to comply with the requirements of the protocol
Exclusion criteria
- 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®
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Highlands Oncology Group, PA — Fayetteville
- University of Arkansas for Medical Sciences — Little Rock
- Highlands Oncology Group, PA — Rogers
- Highlands Oncology Group, PA — Springdale
- Perlmutter Cancer Center at NYU Langone Health — Mineola
- Perlmutter Cancer Center at NYU Langone Health — New York
Identifiers
NCT: NCT05952934 · 275695