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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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: PepCan Biological: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status
Actual Study Start Date : November 13, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PepCan
Vaccine regimen consisting of seven injections of PepCan (50 μg per peptide dose)
Biological: PepCan
PepCan vaccination

Placebo Comparator: Placebo
Vaccine regimen consisting of seven injections of placebo (saline) to mimic PepCan
Biological: Placebo
saline vaccination to mimic PepCan




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821272


Contacts
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Contact: Aaron J Holley 501-686-8274 jaholley@uams.edu
Contact: Omar Atiq, MD 501-526-6990 ext 8176 OTAtiq@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: James Ike Allred, BA, CCRP    501-686-8274    jiallred@uams.edu   
Sub-Investigator: Mayumi Nakagawa, MD, PhD         
Principal Investigator: Omar Atiq, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Omar T Atiq, MD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03821272    
Other Study ID Numbers: 217672
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arkansas:
Squamous cell carcinoma
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms