Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

Colorectal Adenoma Clinical Trial

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients With Newly Diagnosed Advanced Adenomas

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To compare the immunogenicity at week 12 of a MUC1 peptide vaccine with adjuvant (MUC1 peptide-poly-ICLC adjuvant vaccine) (administered at 0, 2, and 10 weeks) in participants with a history of an advanced adenoma, randomized to receive MUC1 peptide vaccine versus placebo.

SECONDARY OBJECTIVES:

I. To evaluate the ability of the vaccine to elicit a long‐term memory response.

II. To compare the adenoma recurrence rate from surveillance exams occurring at least 1 year and up to 3 years after week 0 vaccine administration - MUC1 versus placebo.

III. To compare the adenoma recurrence rates between MUC1 and placebo by excluding the following types of adenomas: participants with adenomas =< 5 mm; participants with adenomatous tissue which may represent residual adenoma at the site of the previous advanced adenoma; participants with adenomatous tissue detected in the same segment of the bowel as the previous advanced adenoma.

IV. To assess adverse events to the MUC1 peptide vaccine in comparison to placebo during Parts I and II.

V. To assess patient reported injection site reaction events from the Vaccine Report Card.

TERTIARY OBJECTIVES:

I. To compare the anti‐MUC1 antibody titer at the time of surveillance colonoscopy for the purpose of evaluating the anti‐MUC1 antibody response in relation to adenoma recurrence.

II. To evaluate MUC1 expression on baseline advanced adenomas and on recurrent adenomas detected at surveillance colonoscopy.

III. To evaluate levels of circulating myeloid derived suppressor cells (MDSC) in the vaccinated and the placebo group and correlate with anti‐MUC1 antibody levels and adenoma recurrence.

IV. To establish a biospecimen repository archive including live cells, plasma, and germline deoxyribonucleic acid (DNA) for future immunologic (e.g. MUC1‐specific T cells) and other assays (systems biology approach to detect differences between responders and non‐responders), testing not currently accommodated within the budget of this trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine subcutaneously (SC) in weeks 0, 2 and 10 and a booster injection in week 53.

ARM II: Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.

After completion of treatment, patients are followed up every 6 months for up to 3 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Adenoma With Severe Dysplasia
• Colorectal Tubulovillous Adenoma

• NCT number: NCT02886000
• Study type: Interventional
• Source: Mayo Clinic
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2014