Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

NCT02134925 | Active Not Recruiting Phase 2 Results DMC

• 6 other identifiers: NCI-2014-01080HHSN261201200042IN01-CN-2012-00042MAY2013-01-01N01CN00042P30CA015083
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)

  The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.

  Week 0 to week 12

Secondary Outcomes (5)

• Adenoma Recurrence Rate

  At least one year and up to 3 years

• Booster Response

  At week 55

• Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site

  Up to 55 weeks

• Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)

  Up to 55 weeks

• Number of Patients With at Least a 2-Fold Increase in the IgG Ratio

  At 12 weeks

Other Outcomes (5)

• Anti-MUC1 Antibody Titer by ELISA

  At approximately week 156

• Change in Levels of Circulating MDSC in Peripheral Blood Mononuclear Cells by Flow Cytometry

  Baseline to up to 3 years

• Change in MUC1 Expression

  Baseline to up to 3 years

Study Arms (2)

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

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Biological: MUC1 Peptide-Poly-ICLC Vaccine; Other: Quality-of-Life Assessment

Arm II (saline)

PLACEBO COMPARATOR

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

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Saline

Interventions

MUC1 Peptide-Poly-ICLC Vaccine BIOLOGICAL

Given SC

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine); Arm II (saline)

Saline OTHER

Given SC

Also known as: ISOTONIC SODIUM CHLORIDE SOLUTION, Normal Saline, Sodium Chloride 0.9%

Arm II (saline)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine); Arm II (saline)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (7)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Robert E. Schoen, M.D., M.P.H
• Organization: University of Pittsburgh

rschoen@pitt.edu

412-864-7078

Study Officials

• Robert E Schoen

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: June 23, 2014
• Primary Completion: January 27, 2017
• Study Completion (Estimated): March 9, 2027
• Last Updated: April 29, 2026
• Results First Posted: May 18, 2018

Record last verified: 2026-03

Locations

PR (1); US (6)