Therapeutic vaccine to reduce cancer recurrence in head and neck cancer patients
A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
This study is testing a new vaccine to see if it can help prevent cancer from coming back in adults who have finished treatment for head and neck cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 6 sites (Fayetteville, Arkansas and 5 other locations) |
| Trial ID | NCT05952934 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the efficacy and safety of a therapeutic vaccine called Candin in adults with squamous cell carcinoma of the head and neck who have completed curative therapy. Participants will receive a total of 7 injections of either Candin or a placebo over a two-year period, with a focus on reducing cancer recurrence rates. The study employs a randomized, double-blind, placebo-controlled design and includes immunological assessments and microbiome diversity analysis at various time points. Up to 100 subjects will be screened to enroll 80 eligible participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with squamous cell carcinoma of the head and neck who have completed curative therapy within the last 120 days and show no evidence of disease.
Not a fit: Patients who are pregnant, breastfeeding, or have allergies to Candin may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce the recurrence of head and neck cancer in patients who have completed their initial treatment.
How similar studies have performed: While this approach is novel, similar therapeutic vaccines have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fayetteville, Arkansas and 5 other locations
- Highlands Oncology Group, PA — Fayetteville, Arkansas, United States (Recruiting)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- Highlands Oncology Group, PA — Rogers, Arkansas, United States (Recruiting)
- Highlands Oncology Group, PA — Springdale, Arkansas, United States (Recruiting)
- Perlmutter Cancer Center at NYU Langone Health — Mineola, New York, United States (Recruiting)
- Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Omar Atiq — University of Arkansas
- Study coordinator: Madison Trujillo
- Email: MTrujillo@uams.edu
- Phone: 501-686-8274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.