BridgeMD
New treatment option for Non-small Cell Lung Cancer (NSCLC)
Official title Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT01720836
What this study is testing
What is Vaccine + PolyICLC?
Vaccine + PolyICLC is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor
- All people 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)
You likely can't join if
- people 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)...
- 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.
See the full eligibility criteria
- people must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor
- All people 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)
- people must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease
- people 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 people 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...
- people 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...
- 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.
- people must not be more than 24 weeks from standard of care treatment for their particular stage of disease
- people 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 people to receive protocol...
- 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...
- Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test
- people with immune deficiency are not expected to respond to the vaccine. Therefore, known HIV-positive patients are excluded from the study
- people with a history of known autoimmune disease are excluded from this study
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.