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Cancer Vaccine
Candin vaccine for Oral Squamous Cell Carcinoma
Phase 2
Recruiting
Led By Omar Atiq
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2 years
Awards & highlights
Study Summary
This trial will test the effectiveness and safety of Candin in reducing cancer recurrence rates over two years. Participants will either receive Candin or a placebo, with more participants receiving Candin. Up to
Who is the study for?
This trial is for adults over 18 with squamous cell carcinoma of the head and neck who've finished curative therapy within the last 120 days and currently show no signs of disease. Participants must be able to follow study procedures and give informed consent.Check my eligibility
What is being tested?
The study tests a vaccine called Candin, given in seven doses over two years, against a saline placebo to see if it can lower cancer recurrence rates. For every three participants receiving Candin, one will get the placebo.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions at the injection site or immune responses due to vaccination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show no signs of cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of clinical efficacy
Secondary outcome measures
Assessment of adverse events
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Candin vaccineActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,191 Total Patients Enrolled
Omar AtiqPrincipal InvestigatorUniversity of Arkansas
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