Status:
COMPLETED
Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
Lead Sponsor:
Robert Schoen
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Risk for Colorectal Cancer
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00773097
Start Date
October 1 2008
End Date
October 1 2012
Last Update
January 7 2019
Active Locations (1)
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1
Digestive Disorders Clinic
Pittsburgh, Pennsylvania, United States, 15213