Vaccine Therapy for Patients with Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02134925
This clinical trial is testing a vaccine to see if it can help the body fight off advanced colon polyps, which are growths that could turn into colorectal cancer. The vaccine aims to boost the immune system to target and destroy these polyps and prevent them from coming back.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring whether a vaccine made from peptides can help the immune system fight off advanced colon polyps, which are growths in the colon that might develop into cancer. The vaccine, called MUC1 peptide-poly-ICLC adjuvant vaccine, is being tested to see if it can prevent these polyps from returning and stop the development of colorectal cancer.
Description
The main goal of this study is to see how well the MUC1 peptide vaccine works in people with a history of advanced adenomas, which are a type of colon polyp. Participants will be randomly assigned to receive either the vaccine or a placebo (a harmless substance that has no effect) at weeks 0, 2, and 10, with a booster shot at week 53.
Researchers will look at how the vaccine affects the immune system's ability to remember and fight off the polyps over time. They will also compare how often the polyps come back in people who get the vaccine versus those who get the placebo. The study will monitor any side effects and reactions at the injection site.
Participants will be followed up every 6 months for up to 3 years to check for any recurrence of polyps and to evaluate the immune response. The study will also collect blood samples and other data to help understand how the vaccine works and to support future research.
Eligibility Criteria
Inclusion Criteria
- Have had at least one advanced colon polyp in the past year, such as:
- A polyp 1 cm or larger
- A polyp with certain cell types (villous or tubulovillous)
- A polyp with high-grade dysplasia (severe abnormal cells)
- All polyps must have been completely removed.
- Able to understand and sign a consent form.
- Willing to undergo screening tests and provide blood samples.
- Not pregnant or nursing, with a negative pregnancy test required for women of childbearing potential.
- Agree to use effective birth control during the study and for a year after the last vaccine dose.
- In good general health with specific blood test results within normal ranges.
Exclusion Criteria
- History of colorectal cancer.
- History of other cancers within the last 5 years, except for certain skin cancers.
- Active infections or uncontrolled medical conditions.
- Immune system disorders or diseases like HIV.
- Genetic conditions that increase cancer risk, like familial adenomatous polyposis.
- Autoimmune diseases like lupus or rheumatoid arthritis.
- Use of certain immune-modulating drugs.
- Allergies to similar vaccines.
- Pregnant or breastfeeding women.
- Certain liver conditions unless discussed with the study team.
- Participation in other clinical trials within the last 3 months, except for certain harmless agents.
- Recent use of oral corticosteroids.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital Cancer Center | 02114 | Boston | Massachusetts |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Kansas City Veterans Affairs Medical Center | 64128 | Kansas City | Missouri |
| Thomas Jefferson University Hospital | 19107 | Philadelphia | Pennsylvania |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| University of Pittsburgh Cancer Institute (UPCI) | 15232 | Pittsburgh | Pennsylvania |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.