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Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

NCT02134925 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-29

Study results available
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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.

Conditions

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

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

MUC1 Peptide-Poly-ICLC Vaccine

Given SC

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Saline

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Robert E Schoen · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-23
Primary Completion
2017-01-27
Completion
2027-03-09

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134925 on ClinicalTrials.gov