MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer (NCT03300817)
🩺 Plain-English Summary (8th-Grade Level)
This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine works in preventing lung cancer in current and former smokers at high risk for lung cancer. Vaccines made from peptides may help the body build an effective immune response to kill cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop the changes from normal to pre-cancer to cancer.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (15 items).
Location: Mayo Clinic in Rochester — Rochester, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- PRE-REGISTRATION EXCLUSION CRITERIA
- History of any malignancy; exceptions: non-melanoma skin cancer or carcinoma in situ (CIS) of the cervix
- Known hepatitis B or C
- Receiving any other investigational agents
- Any prior investigational immune therapy, such as for lung cancer prevention or treatment or for CIS of the cervix
- Use of oral or systemic steroids or other systemic anti-immune therapy =\< 90 days prior to pre-registration; Note: Use of inhaled/nasal steroids and local steroid injections for pain control are not exclusionary
- Known human immunodeficiency virus (HIV)
- Known autoimmune disease
- Known non-alcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MUC1/Poly-ICLC
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Mayo Clinic in Rochester — Rochester, Minnesota
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.