Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 5:27 PM
Study NCT ID:
NCT05952934
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Each study site will received a separate randomization scheme, and the research pharmacy at each site will implement and maintain randomization schedule.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-07-03', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of clinical efficacy', 'timeFrame': 'Through study completion, up to 2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Assessment of adverse events', 'timeFrame': 'Regularly throughout the study, up to 2 years', 'description': 'The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma of Head and Neck']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide informed consent\n* Male or female 18 years of age or older\n* 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.\n* No Evidence of Disease (NED) based on clinical and/or radiographic evaluations\n* Willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Positive urine pregnancy test for women of childbearing potential\n* Being pregnant or attempting to be pregnant with the period of study participation\n* Women who are breast feeding or plan to breast feed within the period of study participation\n* Patients who are allergic to Candin®\n* 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'}, 'identificationModule': {'nctId': 'NCT05952934', 'briefTitle': 'Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence', 'orgStudyIdInfo': {'id': '275695'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Candin vaccine', 'description': "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.", 'interventionNames': ['Biological: 0.5 mL Candin®/injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "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.", 'interventionNames': ['Other: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)']}], 'interventions': [{'name': '0.5 mL Candin®/injection', 'type': 'BIOLOGICAL', 'description': 'Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.', 'armGroupLabels': ['Candin vaccine']}, {'name': 'Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)', 'type': 'OTHER', 'description': 'Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72762', 'city': 'Fayetteville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Worth', 'role': 'CONTACT', 'email': 'Jworth@hogonc.com', 'phone': '479-872-8130'}, {'name': 'Amy Purcell', 'role': 'CONTACT', 'email': 'apurcell@hogonc.com', 'phone': '479-872-8130'}, {'name': 'Joseph T Beck, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Highlands Oncology Group, PA', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Trujillo', 'role': 'CONTACT', 'email': 'MTrujillo@uams.edu'}, {'name': 'Aaron Holley', 'role': 'CONTACT', 'email': 'JAHolley@uams.edu'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '75758', 'city': 'Rogers', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Worth', 'role': 'CONTACT', 'email': 'Jworth@hogonc.com', 'phone': '479-872-8130'}, {'name': 'Amy Purcell', 'role': 'CONTACT', 'email': 'apurcell@hogonc.com', 'phone': '479-872-8130'}, {'name': 'Joseph T Beck, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Highlands Oncology Group, PA', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Worth', 'role': 'CONTACT', 'email': 'Jworth@hogonc.com', 'phone': '479-872-8130'}, {'name': 'Amy Purcell', 'role': 'CONTACT', 'email': 'apurcell@hogonc.com', 'phone': '479-872-8130'}, {'name': 'Joseph T Beck, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Highlands Oncology Group, PA', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zujun Li, MD', 'role': 'CONTACT', 'email': 'Zujun.li@nyulangone.org', 'phone': '(212) 731-6465'}, {'name': 'NYU Langone Health', 'role': 'CONTACT', 'email': 'ct.gov@nyulangone.org'}, {'name': 'Zujun Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Perlmutter Cancer Center at NYU Langone Health', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zujun Li, MD', 'role': 'CONTACT', 'email': 'Zujun.li@nyulangone.org', 'phone': '(212) 731-6465'}, {'name': 'NYU Langone Health', 'role': 'CONTACT', 'email': 'ct.gov@nyulangone.org'}, {'name': 'Zujun Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Perlmutter Cancer Center at NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Madison Trujillo', 'role': 'CONTACT', 'email': 'MTrujillo@uams.edu', 'phone': '501-686-8274'}, {'name': 'Aaron Holley', 'role': 'CONTACT', 'email': 'jaholley@uams.edu', 'phone': '501-686-8274'}], 'overallOfficials': [{'name': 'Omar Atiq', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Highlands Oncology Group, PA', 'class': 'UNKNOWN'}, {'name': 'NYU Langone Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}