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

Primary Purpose

Head and Neck Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PepCan

Placebo

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Squamous cell carcinoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) 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
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)
Blood work done at Screening Visit
1. White count (≥3x109/L acceptable)
2. Hemoglobin (≥ 7 g/dL acceptable)
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 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

Sites / Locations

University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PepCan

Placebo

Arm Description

Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.

Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.

Outcomes

Primary Outcome Measures

Adverse events - evaluate safety of a 7-injection regimen of PepCan.

To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.

Secondary Outcome Measures

Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan

To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.

Full Information

NCT ID

NCT03821272

First Posted

January 23, 2019

Last Updated

July 24, 2023

Sponsor

University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT03821272

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 13, 2019 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

Squamous cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PepCan

Arm Type

Experimental

Arm Description

Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.

Intervention Type

Biological

Intervention Name(s)

PepCan

Other Intervention Name(s)

HPV 16 E6 peptides combined with Candin®, PepCan Vaccine Regime

Intervention Description

50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities

Intervention Type

Biological

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline, Placebo Vaccine Regimen

Intervention Description

0.9% Saline solution per dose administered intradermally in the extremities

Primary Outcome Measure Information:

Title

Adverse events - evaluate safety of a 7-injection regimen of PepCan.

Description

To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan

Description

To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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) 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omar T Atiq, MD

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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