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| Name | Class |
|---|---|
| Highlands Oncology Group, PA | UNKNOWN |
| NYU Langone Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candin vaccine | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical efficacy | 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. | Through study completion, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events | The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed. | Regularly throughout the study, up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madison Trujillo | Contact | 501-686-8274 | MTrujillo@uams.edu | |
| Aaron Holley | Contact | 501-686-8274 | jaholley@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Omar Atiq | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group, PA | Recruiting | Fayetteville | Arkansas | 72762 | United States |
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This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.
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Each study site will received a separate randomization scheme, and the research pharmacy at each site will implement and maintain randomization schedule.
| 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. |
|
| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
|
| Highlands Oncology Group, PA | Recruiting | Rogers | Arkansas | 75758 | United States |
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| Highlands Oncology Group, PA | Recruiting | Springdale | Arkansas | 72762 | United States |
|
| Perlmutter Cancer Center at NYU Langone Health | Recruiting | Mineola | New York | 11501 | United States |
|
| Perlmutter Cancer Center at NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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