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NCT02134925Active, not recruitingPhase 2

Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients With Newly Diagnosed Advanced Adenomas

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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 over time. 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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
110 (actual)
First submitted
7 May 2014
Start date
23 Jun 2014
Primary completion date
27 Jan 2017
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT02134925

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 110
  • From 23 Jun 2014 to the primary completion date, 27 Jan 2017
  • 7 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or planned use of immunomodulators including: infliximab, 6-MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
  • Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) \>= 5; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =\< 2 are eligible for enrollment; participants with NAS of 3-4 must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake)
  • 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

Other illness

  • History of any colorectal 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
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent

Age

  • History of other malignancy =\< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer

Other

  • Pregnant women
  • Breastfeeding women

Who the study is looking for

  • 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) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =\< 1:160, negative, or \< 1.0

Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Puerto Rico
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Massachusetts General Hospital Cancer Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Kansas City Veterans Affairs Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Thomas Jefferson University Hospital
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
UPMC Hillman Cancer Center
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.