Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant Vaccine in Patients With Localized and Locally Advanced Non-Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how the body's immune system responds to the MUC1 vaccine in adults with certain stages of non-small cell lung cancer or a neuroendocrine carcinoid tumor. Everyone gets a shot under the skin every 3 weeks for 3 doses. People whose immune system responds may get yearly booster shots for up to 10 years after their last vaccine.
All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 10 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have non-small cell lung cancer or a neuroendocrine carcinoid tumor confirmed by tissue or cell tests.
- Have one of these stages: IA (T1N0), IB (T2N0), II, IIIA without N2 lymph node spread, IIIA with N2 spread, or IIIB with N3 spread. These codes describe tumor size and spread to lymph nodes.
- Have stable cancer, meaning it is not getting worse.
- Be fully active or able to walk and do light work (ECOG score 0–1).
- Be within 4 to 24 weeks of standard treatment for your cancer stage.
- Have blood counts and organ function that meet the study's lab test limits.
- If you or your partner could become pregnant, use effective birth control during study treatment and for at least 3 months after. Report a possible pregnancy to your doctor right away.
Who can't join
- You are getting another experimental treatment, have had vaccine therapy before, or are taking steroids or other drugs that reduce immune activity.
- You have had another cancer, except non-melanoma skin cancer. Earlier surgery to remove lung cancer is allowed if it was at least 5 years ago.
- You have an ANA blood test result above 1:160 or a history of autoimmune disease, where the immune system attacks the body. An ANA result of 1:160 or lower is allowed if you have no symptoms and otherwise qualify.
- You have hepatitis B or C and take drugs that change immune activity, such as interferon.
- You have HIV.
- You have pneumonia behind a blocked airway, another serious infection, or a serious health problem that could prevent study treatment.
- You have an uncontrolled illness, such as heart failure with symptoms, unstable chest pain, or an abnormal heartbeat, or mental health or social problems that could keep you from following study requirements.
- You are pregnant. Women who could become pregnant must have a negative pregnancy test.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor * All subjects must have one of the following stages: Stage IA(T1NO); IB (T2NO), II \& IIIA (N2 negative); IIIA (N2+), IIIB (N3+) * Patients must have stable disease at the time of enrollment * Women and men at least 18 years of age * ECOG performance status 0-1(Appendix A) * Subjects must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease * Subjects must have acceptable organ and marrow function as defined below: * Leukocytes \> 3,000/µL * Absolute Neutrophils \> 1,500/µL * Hemoglobin \> 10 g/dL * Platelets \> 100,000/µL * Total Bilirubin within normal institutional limits * Creatinine within normal institutional limits OR * Creatinine clearance \> 60 mL/min/1.73 m2 for subjects with above normal AST and ALT with alkaline phosphatase within \< 1.5 times upper limit of normal * The effects of a MUC1vaccine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men and women of childbearing potential must be willing to use effective contraception (hormonal barrier method of birth control; abstinence) while on study treatment and for at least 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Subjects may not be receiving any other investigational agents \- No history of prior malignancy, except for non-melanoma skin cancer * Any positive ANA titer above 1:160, even in an asymptomatic individual. Note: Weakly positive ANA defined as ANA titers up to 1:160 maximum (≤ 1:160) will be acceptable in an asymptomatic individual who is otherwise eligible for the study. * Known Hepatitis B on immunomodulators (i.e. interferon) * Known Hepatitis C on immunomodulators (i.e. interferon) * No prior vaccine therapy * Patients may not be receiving any steroids or other anti-immune therapy at the time of registration. * Subjects must not be more than 24 weeks from standard of care treatment for their particular stage of disease * Subjects must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the subjects to receive protocol treatment * Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration * 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 * Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test * Subjects with immune deficiency are not expected to respond to the vaccine. Therefore, known HIV-positive patients are excluded from the study * Subjects with a history of known autoimmune disease are excluded from this study
Study sites (1)
PA
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232More trials in Pittsburgh