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A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821272
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE January 23, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
To evaluate the safety of a 7-injection regimen of PepCan. [ Time Frame: 2 years ]
Adverse events will be captured based on NCI CTCAE Version 5.0 and will be assessed whether they are treatment-related or not by a physician.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Safety will be assessed by recording the numbers and types of adverse events determined to be vaccine-related. [ Time Frame: 2 years ]
Adverse events will be captured based on NCI CTCAE Version 5.0 and will be assessed whether they are treatment-related or not by a physician.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
To evaluate the efficacy of a 7 injection regimen of PepCan by observing cancer recurrence. [ Time Frame: 2 years ]
Cancer recurrence rates will be compared between the PepCan and placebo arms.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Efficacy will be assessed by comparing recurrence rates between vaccinated and unvaccinated. [ Time Frame: 2 years ]
Cancer recurrence rates will be compared for a 2-year period between the clinical trial subjects and other patients at the same institution with head and neck cancer who achieve remission but who are not participating in this clinical trial.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients
Official Title  ICMJE A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status
Brief Summary This current 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 achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.
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 total of 7 injections of PepCan (50 µg per peptide 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 by enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and 9), and by fluorescent activated cell sorter analysis will be made at times points at Visits 1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
7 injections of PepCan (50 μg per peptide dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Biological: PepCan
    PepCan vaccination
  • Biological: Placebo
    saline vaccination to mimic PepCan
Study Arms  ICMJE
  • Experimental: PepCan
    Vaccine regimen consisting of seven injections of PepCan (50 μg per peptide dose)
    Intervention: Biological: PepCan
  • Placebo Comparator: Placebo
    Vaccine regimen consisting of seven injections of placebo (saline) to mimic PepCan
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Able to provide informed consent
  2. Male or female 18 years of age or older
  3. Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) therapy within the previous 90 days with negative surgical margins and/or without evidence of disease radiologically by a scan such as computer tomography and/or positive emission tomography.
  4. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
  5. No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
  6. Vital Signs recorded

    1. Blood pressure (≤160/95 mm Hg acceptable)
    2. Heart rate (50-100 beats per min acceptable)
    3. Respiratory rate (≥ 12 ≤25 breaths per min acceptable)
    4. Temperature (≤100°F acceptable)
  7. Blood work done at Screening Visit

    1. White count (≥3x109/L acceptable)
    2. Hemoglobin (≥ 7 g/dL acceptable)
  8. Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  1. Positive urine pregnancy test for women of childbearing potential
  2. Being pregnant or attempting to be pregnant with the period of study participation
  3. Women who are breast feeding or plan to breast feed within the period of study participation
  4. Patients who are allergic to Candin® or yeast
  5. History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
  6. Patients who have previously received PepCan
  7. History of recurrence of squamous cell carcinoma of the head and neck
  8. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aaron J Holley 501-686-8274 jaholley@uams.edu
Contact: Omar Atiq, MD 501-526-6990 ext 8176 OTAtiq@uams.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821272
Other Study ID Numbers  ICMJE 217672
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omar T Atiq, MD University of Arkansas
PRS Account University of Arkansas
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP