Vaccine Therapy for Advanced Colon Polyps

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byRobert E Schoen

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

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Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.

Research Team

Robert E Schoen

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

Hemoglobin greater than 90% of the lower limit of institutional normal

Platelets >= 100 B/L (10^9/L)

Alkaline phosphatase =< 1.5 x institutional upper limit of normal

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Exclusion Criteria

I have been diagnosed with NASH and my liver disease score is 5 or higher.

I haven't taken oral steroids in the last 12 weeks.

I haven't had any cancer except for skin cancer in the last 5 years.

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Treatment Details

Interventions

MUC1 Peptide-Poly-ICLC Vaccine (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

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.