Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-002350
NCT ID: NCT02134925
Sponsor Protocol Number: MAY2013-01-01
About this study
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 overtime. 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- 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
- Alkaline phosphatase ≤ 1.5 x institutional upper limit of normal
- Total bilirubin ≤ 1.5 x institutional upper limit of normal
- Blood urea nitrogen (BUN) ≤ 1.5 x institutional upper limit of normal
- Creatinine ≤ 1.5 x institutional upper limit of normal
- Antinuclear antibody (ANA) ≤ 1:160
- 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Lisa Boardman, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office