Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

NCT ID: NCT02134925

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-23
• Study Completion Date: 2026-03-06

Brief 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.

Detailed 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.

Conditions

Colorectal Adenoma; Colorectal Adenoma With Severe Dysplasia; Colorectal Carcinoma; Colorectal Tubulovillous Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine)

Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

MUC1 Peptide-Poly-ICLC Vaccine

Intervention Type: BIOLOGICAL

Given SC

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm II (saline)

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

Group Type: PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Saline

Intervention Type: OTHER

Given SC

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

MUC1 Peptide-Poly-ICLC Vaccine

Given SC

Intervention Type: BIOLOGICAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Saline

Given SC

Intervention Type: OTHER

Other Intervention Names

Quality of Life Assessment; ISOTONIC SODIUM CHLORIDE SOLUTION; Normal Saline; Sodium Chloride 0.9%

Eligibility Criteria

Inclusion Criteria

• History of at least one of the following conditions in the previous 12 months:

• Colorectal adenoma(s) >= 1 cm in maximal diameter
• Colorectal adenoma(s) with villous or tubulovillous histology
• Colorectal adenoma(s) with high grade (severe) dysplasia
• Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to undergo screening tests and procedures
• Willingness to provide blood samples for toxicity monitoring and research purposes
• Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =< 7 days prior to registration/randomization for women of childbearing potential
• Willingness to employ adequate contraception through week 53 of the study; note: women of childbearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry and for the period of active vaccination (through week 53); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her physician immediately
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
• Hemoglobin greater than 90% of the lower limit of institutional normal
• Platelets >= 100 B/L (10^9/L)
• White blood cell (WBC) > 2.5 B/L (10^9/L)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
• Alkaline phosphatase =< 1.5 x institutional upper limit of normal
• Total bilirubin =< 1.5 x institutional upper limit of normal
• Blood urea nitrogen (BUN) =< 1.5 x institutional upper limit of normal
• Creatinine =< 1.5 x institutional upper limit of normal
• Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =< 1:160, negative, or < 1.0

Exclusion Criteria

• History of any colorectal cancer
• History of other malignancy =< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer
• Presence of an active acute or chronic infection or uncontrolled illness including, but not limited to unstable congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Acquired immunosuppressive diseases such as active human immunodeficiency virus (HIV) infection or congenital diseases of immunity
• History of heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC])
• History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto's thyroiditis, or Grave's disease
• Current or planned use of immunomodulators including: infliximab, 6-MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent
• Pregnant women
• Breastfeeding women
• Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) >= 5; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =< 2 are eligible for enrollment; participants with NAS of 3-4 must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake)
• Receiving any other investigational agent =< 3 months prior to registration/randomization, except innocuous agents with no known interaction with the study agent (e.g., standard dose multivitamins or topical agents for limited skin conditions)
• Any use of oral corticosteroids =< 12 weeks prior to registration/randomization

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert E Schoen

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

University of Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2014-01080

Identifier Type: REGISTRY

Identifier Source: secondary_id

HHSN261201200042I

Identifier Type: -

Identifier Source: secondary_id

N01-CN-2012-00042

Identifier Type: -

Identifier Source: secondary_id

MAY2013-01-01

Identifier Type: OTHER

Identifier Source: secondary_id

MAY2013-01-01

Identifier Type: OTHER

Identifier Source: secondary_id

N01CN00042

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2014-01080

Identifier Type: -

Identifier Source: org_study_id

NCT02886000

Identifier Type: -

Identifier Source: nct_alias