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Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

RE
Overseen byRobert E Schoen
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Robert Schoen
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring. MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is expressed in a larger amount and in a modified form on adenomatous polyps and colorectal cancer. These changes in MUC1 are thought to be part of the process of progression from adenomas toward cancer. The goal of a vaccine is to help the immune system in the body identify the changes in MUC1 that accompany the progression to cancer and eliminate the abnormal cells that make abnormal MUC1.

Research Team

RE

Robert E Schoen

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

-Age 40 - 70 years of age.
History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
Colorectal adenoma(s) ≥ 1 cm in maximal diameter
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Treatment Details

Interventions

  • MUC1 - Poly ICLC (Cancer Vaccine)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MUC1 Poly-ICLCExperimental Treatment1 Intervention

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Who Is Running the Clinical Trial?

Robert Schoen

Lead Sponsor

Trials
1
Recruited
50+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School