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

NCT00773097 | Completed Phase 2 Results DMC

• 1 other identifier: PRO07030214
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Risk for Colorectal Cancer

Keywords

Prevention; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Anti Muc-1 Antibody

  Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.

  52 weeks

Secondary Outcomes (2)

• Number of Participants With Autoimmune Response to Muc-1 Vaccine

  52 weeks

• Number of Participants With Adverse Events Associated With the Study Agent

  54 weeks

Study Arms (1)

MUC1 Poly-ICLC

EXPERIMENTAL

Biological: MUC1 - Poly ICLC

Interventions

MUC1 - Poly ICLC BIOLOGICAL

The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.

MUC1 Poly-ICLC

Eligibility Criteria

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

You may qualify if:

• 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
• Colorectal adenoma(s) with villous or tubulovillous histology
• Colorectal adenoma(s) with high-grade dysplasia
• Willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
• ECOG performance status 0 or 1
• Hemoglobin greater than 95% of the lower limit of institutional normal. Platelets ≥100,000/µL.
• AST (SGOT), ALT (SGPT), alkaline phosphatase, total bilirubin, BUN, creatinine ≤ 1.5x upper limit of institutional normal.
• ANA \< 1:160

You may not qualify if:

• Receiving any other investigational agents.
• Presence of an active acute or chronic infection
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
• History of heritable cancer syndrome (FAP, HNPCC)
• Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
• History of malignancy \< 5 years prior to the Registration/Randomization evaluation, excluding non-melanoma skin cancer.
• Any use of oral corticosteroids ≤ 12 weeks prior to Registration/Randomization.
• Current or planned use of immunomodulators including: Remicade, 6-MP (Mercaptopurine), Methotrexate, cyclosporine, or other immunomodulatory drugs.
• Pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. Breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.

Sponsors & Collaborators

• Robert Schoen: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Digestive Disorders Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Kimura T, McKolanis JR, Dzubinski LA, Islam K, Potter DM, Salazar AM, Schoen RE, Finn OJ. MUC1 vaccine for individuals with advanced adenoma of the colon: a cancer immunoprevention feasibility study. Cancer Prev Res (Phila). 2013 Jan;6(1):18-26. doi: 10.1158/1940-6207.CAPR-12-0275. Epub 2012 Dec 17.

  PMID: 23248097 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

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

Results Point of Contact

• Title: Robert E. Schoen ME
• Organization: University Pittsburgh

rschoen@pitt.edu

412-648-9115

Study Officials

• Robert E Schoen

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: January 7, 2019
• Results First Posted: February 3, 2014

Record last verified: 2019-01

Locations

US (1)