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

Primary Purpose

Risk for Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MUC1 - Poly ICLC

About this trial

This is an interventional prevention trial for Risk for Colorectal Cancer focused on measuring Prevention, Colorectal Cancer

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).
1. Colorectal adenoma(s) ≥ 1 cm in maximal diameter
2. Colorectal adenoma(s) with villous or tubulovillous histology
3. 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

Exclusion Criteria:

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.

Sites / Locations

Digestive Disorders Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MUC1 Poly-ICLC

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Autoimmune Response to Muc-1 Vaccine

Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.

Number of Participants With Adverse Events Associated With the Study Agent

Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.

Full Information

NCT ID

NCT00773097

First Posted

October 15, 2008

Last Updated

January 3, 2019

Sponsor

Robert Schoen

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00773097

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Robert Schoen

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine among subjects at increased risk for colorectal cancer by virtue of a history of advanced adenoma. The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1. Among the secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced, has an effect on the recurrence of polyps. Subjects with a history of advanced adenoma will be recruited for MUC1 vaccination. Vaccine will be administered at weeks 0, 2, and 10. Some subjects may have pre-existing immunity to MUC1, and this will be accounted for in the analytic phase. However, all subjects will be administered the vaccine, regardless of baseline antibody status. To insure accurate standardization in measurement and assessment of antibody levels, assays for baseline antibody status will be done at the same time as those for response to vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Risk for Colorectal Cancer

Keywords

Prevention, Colorectal Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MUC1 Poly-ICLC

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

MUC1 - Poly ICLC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Anti Muc-1 Antibody

Description

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.

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Autoimmune Response to Muc-1 Vaccine

Description

Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.

Time Frame

52 weeks

Title

Number of Participants With Adverse Events Associated With the Study Agent

Description

Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.

Time Frame

54 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert E Schoen

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Digestive Disorders Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23248097

Citation

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.

Results Reference

result

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

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