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 range55 Years – 80 Years
SexALL
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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…
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