Squamous Cell Carcinoma of Head and Neck
Conditions
Brief 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.
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
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.
Sponsors
University of Arkansas
Highlands Oncology Group, PA
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Each study site will received a separate randomization scheme, and the research pharmacy at each site will implement and maintain randomization schedule.
Intervention model description
This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of clinical efficacy | Through study completion, up to 2 years | Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse events | Regularly throughout the study, up to 2 years | The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed. |
Countries
United States
Contacts
CONTACTMadison Trujillo
CONTACTAaron Holley
PRINCIPAL_INVESTIGATOROmar Atiq
University of Arkansas
Outcome results
None listed