Status:
COMPLETED
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients
Lead Sponsor:
University of Arkansas
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieve...
Detailed Description
This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be receiving a t...
Eligibility Criteria
Inclusion
- 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) therapy within the previous 120 days
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
- No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
- Vital Signs recorded
- Blood pressure (≤160/95 mm Hg acceptable)
- Heart rate (50-100 beats per min acceptable)
- Respiratory rate (≥ 12 ≤25 breaths per min acceptable)
- Temperature (≤100°F acceptable)
- Blood work done at Screening Visit
- White count (≥3x109/L acceptable)
- Hemoglobin (≥ 7 g/dL acceptable)
- Willing and able to comply with the requirements of the protocol
Exclusion
- Positive urine pregnancy test for women of childbearing potential
- Being pregnant or attempting to be pregnant within 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® or yeast
- History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
- Patients who have previously received PepCan
- History of recurrence of squamous cell carcinoma of the head and neck
- If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter or continue in this study
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03821272
Start Date
November 13 2019
End Date
February 3 2025
Last Update
October 8 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205