Phase 2
N=46
Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
Risk for Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00773097 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Number of Participants With Anti Muc-1 Antibody — 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MUC1 - Poly ICLC (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Robert Schoen
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anti Muc-1 Antibody |
39 | — |
| SECONDARY Number of Participants With Autoimmune Response to Muc-1 Vaccine |
39 | — |
| SECONDARY Number of Participants With Adverse Events Associated With the Study Agent |
39 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00773097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.