Study on the Immune Response of MUC1 Peptide Vaccine for Non-Small Cell Lung Cancer

Sponsor: Olivera Finn

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01720836

Provider View

This clinical trial is testing a vaccine designed to boost the immune system's response against non-small cell lung cancer (NSCLC). Participants will receive the vaccine every three weeks for three doses, with optional yearly booster shots for up to five years if they respond well to the treatment.

Patient Parameters

Program Overview

The study aims to evaluate the immune response to a vaccine targeting MUC1, a protein often found in non-small cell lung cancer (NSCLC). Participants will receive the vaccine under the skin every three weeks for a total of three doses. Those who respond well may receive yearly booster shots for up to five years. The vaccine is combined with an adjuvant called Poly-ICLC, which has been used safely in other cancer trials. Researchers will closely monitor the immune response to the vaccine in patients with NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor.
  • Cancer must be at specific stages: Stage IA, IB, II, IIIA, or IIIB.
  • Disease must be stable at the time of joining the study.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must be within 4 to 24 weeks of completing standard treatment for their cancer stage.
  • Must have adequate organ and bone marrow function, including:
    • White blood cell count over 3,000/µL.
    • Neutrophil count over 1,500/µL.
    • Hemoglobin over 10 g/dL.
    • Platelet count over 100,000/µL.
    • Normal bilirubin and creatinine levels.
  • Must agree to use effective birth control during the study and for at least 3 months after the last vaccine dose.

Exclusion Criteria

  • Cannot be receiving other experimental treatments.
  • No history of other cancers, except non-melanoma skin cancer.
  • Cannot have a positive ANA test above 1:160 unless asymptomatic.
  • Cannot have Hepatitis B or C if on immunomodulators.
  • No prior vaccine therapy.
  • Cannot be on steroids or other immune-suppressing treatments.
  • Must not be more than 24 weeks from standard treatment.
  • Cannot have serious infections or medical conditions that would interfere with the study.
  • Prior lung cancer surgery is allowed if it was over five years ago.
  • Cannot have uncontrolled illnesses like heart failure or psychiatric conditions.
  • Pregnant women are not allowed; women of childbearing potential must have a negative pregnancy test.
  • Cannot have immune deficiencies or be HIV-positive.
  • Cannot have a history of autoimmune diseases.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.