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Cancer Vaccine
PepCan for Head and Neck Cancer
Phase 1 & 2
Waitlist Available
Led By Omar T Atiq, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test if seven injections of PepCan over two years can help prevent HPV-related head and neck cancers from coming back. They will also look at side effects and changes in the gut microbiome.
Who is the study for?
Adults over 18 who've had squamous cell carcinoma of the head and neck, are now in remission after curative therapy, and have a stable health status (specific vital signs and blood counts). Excluded are those with severe recent asthma issues, past cancer recurrence, pregnant or breastfeeding women, yeast allergy sufferers, or previous PepCan recipients.Check my eligibility
What is being tested?
The trial is testing PepCan's safety and effectiveness against a placebo in preventing cancer recurrence. Participants will receive seven injections over two years. The study also looks at immune response and gut microbiome changes.See study design
What are the potential side effects?
While specific side effects of PepCan aren't listed here, common reactions to new treatments may include local injection site reactions, flu-like symptoms such as fever or fatigue, allergic responses, or gastrointestinal disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
My tests show no signs of cancer.
Select...
I have completed treatment for head or neck cancer within the last 4 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events - evaluate safety of a 7-injection regimen of PepCan.
Secondary outcome measures
Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan
Side effects data
From 2022 Phase 2 trial • 81 Patients • NCT0248141490%
Injection Site Reaction
29%
Nausea
29%
Headache
24%
Hypokalemia
21%
Myalgia
21%
Hypoalbuminemia
17%
Anemia
17%
Fatigue
17%
Aspartate Aminotransferase Increased
14%
Skin and Subcutaneous Tissue Disorders - Other, Specify
12%
Dizziness
12%
Alanine Aminotransferase Increased
12%
Vaginal Infection
10%
Hypocalcemia
10%
Infections and Infestations - Others, Specify
10%
Urinary Tract Infection
10%
Fever
10%
Flu-like Symptoms
10%
Gastrointestinal Disorders - Other, Specify
10%
Pain
7%
Creatinine Increased
7%
Hypothyroidism
7%
Back Pain
7%
Anxiety
7%
Vaginal Hemorrhage
7%
Unintended Pregnancy
5%
Depression
5%
White Blood Cell Decreased
5%
Bruising
5%
Abdominal Pain
5%
Diarrhea
5%
Investigations - Other, Specify
5%
Hemoglobin Increased
5%
Dyspareunia
5%
Irregular Menstruation
5%
Allergic Rhinitis
5%
Dyspnea
5%
Bone Pain
5%
Sore Throat
5%
Reproductive System and Breast Disorders - Other, Specify
2%
Breast Pain
2%
Rash Acneiform
2%
Somnolence
2%
Hemturia
2%
Urinary Urgency
2%
Muscle Weakness Upper Limb
2%
Osteoporosis
2%
Nasal Congestion
2%
Paresthesia
2%
Bloating
2%
Upper Respiratory Infection
2%
Sinus Bradycardia
2%
Stomach Pain
2%
Chest Pain - Cardiac
2%
Vomitting
2%
Colitis
2%
Gastrointestinal Pain
2%
Fetal Death
2%
Eye Disorders 0 Other, Specify
2%
Edema Limbs
2%
Localized Edema
2%
Constipation
2%
Alkaline Phosphatase Increased
2%
Obesity
2%
Erythema Multiforme
2%
Hot Flashes
2%
Blood Bilirubin Increased
2%
Non-Cardiac Chest Pain
2%
Platelet Count Decreased
2%
Dehydration
2%
Hyponatremia
2%
Hypotension
2%
Pain in Extremity
2%
Skin Infection
2%
Hyperglycemia
2%
Hypertension
2%
Vaginal Pain
2%
Cough
2%
Alopecia
2%
Skin Ulceration
2%
Appendicitis
2%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Candin
PepCan
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PepCanExperimental Treatment1 Intervention
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
Group II: PlaceboPlacebo Group1 Intervention
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Candida albicans
FDA approved
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,332 Total Patients Enrolled
Omar T Atiq, MDPrincipal InvestigatorUniversity of Arkansas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to get out of my bed or chair and move around.I am 18 years old or older.My tests show no signs of cancer.I am not pregnant.My cancer in the head or neck area has come back.You have had severe asthma that required a visit to the emergency room or being admitted to the hospital in the past five years.I have previously received PepCan treatment.I have completed treatment for head or neck cancer within the last 4 months.You are allergic to Candin® or yeast.
Research Study Groups:
This trial has the following groups:- Group 1: PepCan
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently searching for participants?
"Affirmative, the details available on clinicaltrials.gov indicate that this study is currently recruiting individuals for participation. The trial was first advertised in November 2019 and last revised October 2022. This experiment requires 20 test subjects from a single medical center to take part."
Answered by AI
Could you provide the aggregate figure for participants enrolled in this clinical trial?
"Affirmative. The information on clinicaltrials.gov pronounces that recruitment for this experiment is in progress. Initially posted on November 13th 2019, the trial was last updated October 18th 2022 and aims to recruit 20 participants from a single site."
Answered by AI
Am I eligible to join this investigation?
"This trial is seeking 20 applicants with head malignancies, ranging between 18 and 100 years of age. Essential eligibility criteria include a respiratory rate no lower than 12 nor higher than 25 breaths per minute, an ECOG performance status between 0-2, a heart rate that oscillates between 50 to 100 beats per minute, in addition to being either male or female aged over 18 years old."
Answered by AI
Are adolescents accepted in this investigation?
"The parameters for participation in this research trial require that individuals are aged between 18 and 100 years old."
Answered by AI
Could you please elucidate on any other investigations that have been done concerning PepCan?
"Presently, 3 clinical trials related to PepCan are ongoing. Not one of these is in its third phase; however, there are three medical centres operating studies for this treatment - all based in Little Rock, Arkansas."
Answered by AI
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