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Cancer Vaccine

Vaccine Therapy for Advanced Colon Polyps

Phase 2
Waitlist Available
Led By Robert E Schoen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial looks at a new vaccine for patients with advanced colon polyps. The vaccine is made from peptides and may help the body build an effective immune response to kill polyp cells.

Who is the study for?
This trial is for adults with newly diagnosed advanced colon polyps at least 1 cm in size, with severe dysplasia or certain histologies, and all lesions must be removed prior to the study. Participants need normal organ function tests, not pregnant/nursing, willing to use contraception and provide blood samples. Excluded are those with any colorectal cancer history within 5 years (except some skin cancers), autoimmune diseases, uncontrolled illnesses, or using immunomodulators.Check my eligibility
What is being tested?
The trial is testing a vaccine therapy called MUC1 peptide-poly-ICLC adjuvant vaccine on patients with advanced colon polyps to see if it can prevent these polyps from turning into colorectal cancer by boosting the body's immune response against them. It also aims to prevent recurrence of polyps.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to vaccines such as soreness at injection site, fever, fatigue and muscle pain. Since this involves stimulating the immune system there could also be risks of auto-immune responses or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am mostly active and can care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
Secondary outcome measures
Adenoma Recurrence Rate
Booster Response
Number of Patients With at Least a 2-Fold Increase in the IgG Ratio
+2 more
Other outcome measures
Anti-MUC1 Antibody Titer by ELISA
Change in Levels of Circulating MDSC in Peripheral Blood Mononuclear Cells by Flow Cytometry
Change in MUC1 Expression
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine)Experimental Treatment3 Interventions
Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
Group II: Arm II (saline)Placebo Group3 Interventions
Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,015 Total Patients Enrolled
5 Trials studying Colorectal Adenomas
6,030 Patients Enrolled for Colorectal Adenomas
Robert E SchoenPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

MUC1 Peptide-Poly-ICLC Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02134925 — Phase 2
MUC1 Peptide-Poly-ICLC Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02134925 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it currently possible to join the research study?

"As indicated by the clinicaltrials.gov listing, this trial is not presently seeking participants. This study was initially published on June 23rd 2014 and last modified on August 11th 2022. Despite its inactive status, there are still 95 other trials actively recruiting candidates right now."

Answered by AI

Is it possible for me to join this experiment?

"This clinical trial seeks 110 patients with adenoma that are between 40 and 70 years of age. Essential qualifications include: colorectal adenoma(s) exhibiting severe dysplasia, villous or tubulovillous histology, evidence that all affected lesions have been removed completely, a maximal size of over 1 cm in diameter, understanding and consent to written informed documentation, compliance with screening tests and procedures including blood samples for toxicity monitoring and research purposes, negative pregnancy test within 7 days prior to study registration/randomization for women capable of bearing children; employ adequate contraception throughout the 53 week period; ECOG performance status"

Answered by AI

What risks should be taken into account when administering the MUC1 Peptide-Poly-ICLC Vaccine?

"After careful consideration, our team at Power evaluated the safety of MUC1 Peptide-Poly-ICLC Vaccine to be a 2 as this is still in Phase 2 trials. While there has been evidence pointing towards its security, we have yet to see any data supporting efficacy."

Answered by AI

Are there multiple locations in Canada where this investigation is being conducted?

"There are 6 trial sites currently accepting patients, which includes the prestigious Massachusetts General Hospital Cancer Center in Boston and Fox Chase Cancer Center in Pittsburgh. Additionally, University of Pittsburgh Cancer Institute (UPCI) is located in Kansas City with 3 other centres conducting this research study."

Answered by AI

Is this scientific trial accepting participants aged forty and above?

"To be eligible for this medical trial, a participant must have surpassed their fortieth birthday and not yet reached their seventy-first."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
2014. "Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02134925.
~10 spots leftby Apr 2025
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