Immune response to a MUC1 peptide vaccine for 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
This study is testing a new vaccine for lung cancer to see if it can help boost the immune response in people with non-small cell lung cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT01720836 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the immune response generated by a MUC1 peptide vaccine in patients with non-small cell lung cancer (NSCLC). Participants will receive the vaccine subcutaneously every three weeks for three doses, with optional yearly booster shots for up to five years for those who respond positively. The study aims to characterize the anti-MUC1 immune response and assess the safety and immunogenicity of the vaccine, which has shown promise in other cancer types. The vaccine is administered alongside an adjuvant, Poly-ICLC, to enhance the immune response.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed non-small cell lung cancer at specific stages and stable disease.
Not a fit: Patients with advanced stages of lung cancer or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a novel immunotherapy option for patients with non-small cell lung cancer.
How similar studies have performed: Other studies using similar peptide vaccine approaches have shown promise, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Arjun Pennathur, MD — University of Pittsburgh Medical Center
- Study coordinator: Research Coordinator
- Email: wardj@upmc.edu
- Phone: 412-647-8583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.