MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer (NCT03300817) | Clinical Trial Compass
Active — Not RecruitingPhase 1
MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer
United States50 participantsStarted 2017-12-27
Plain-language summary
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 participate
Age range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION INCLUSION CRITERIA
* Smoking history of \>= 30 pack-years AND either current smoker (still smoking or quit \< 1 year prior to pre-registration) OR former smoker (quit 1-15 years prior to pre-registration); Note: Pack years is determined by multiplying the number of packs smoked per day by the number of years smoked
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Computed tomography (CT) scan of the chest done =\< 6 months prior to pre-registration showing either negative findings (no nodules) or solid or part-solid nodules \< 6 mm in size (consistent with \< 1% probability of malignancy, Lung-Reporting and Data Systems \[RADs\] version 1.0)
* Willingness to employ adequate contraception, if applicable; Note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* REGISTRATION INCLUSION CRITERIA
* Leukocytes (white blood cell \[WBC\]) \>= 3,000/microliter
* Neutrophils (absolute neutrophil count \[ANC\]) \>= 1,500/microliter
* Platelets \>= 100,000/microliter
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) Note: Highe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on safety and immune response rather than proving the vaccine prevents lung cancer, what does that mean for what we actually know so far about whether it works?
2The trial is measuring Grade 3 or higher adverse events — what kinds of serious side effects have been seen in MUC1 vaccine studies, and how would those affect my day-to-day life if they occurred?
3The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new participants — does that affect my options here, and are there similar vaccine or immunoprevention trials I might still be eligible for?
4Given that this vaccine is aimed at people at high risk for lung cancer due to smoking history, how does my specific risk profile compare to the kind of participants this trial was designed for, and would a preventive approach like this make sense alongside other screening I might already be doing?
5If I'm not able to join this trial, are there other approaches — like low-dose CT screening or other prevention strategies — that my care team would recommend while results from studies like this are still being evaluated?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Immunogenicity of the MUC1 Vaccine
Timeframe: At week 12
2
Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment