RecruitingPhase 1Phase 2NCT01720836

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

Sponsor

Olivera Finn

Enrollment

30 participants

Start Date

Nov 1, 2012

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)

Summary

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a vaccine targeting a protein called MUC1 can help the immune system fight non-small cell lung cancer or a related lung tumor (carcinoid) after standard treatment. **You may be eligible if...** - You have been confirmed to have non-small cell lung cancer (NSCLC) or a neuroendocrine carcinoid tumor of the lung - Your cancer is at a specific stage (Stage IA through IIIB) - Your disease is currently stable - You are 18 or older and in good physical condition - You completed standard cancer treatment 4 to 24 weeks ago - Your blood counts and organ functions are within acceptable limits **You may NOT be eligible if...** - You are currently taking part in another experimental drug study - You have a history of another cancer (except non-melanoma skin cancer) - You have a known autoimmune disease - You are HIV positive - You are on steroids or immune-suppressing medications at the time of enrolment - You are pregnant or breastfeeding - You have had a prior cancer vaccine - You have an active serious infection or other severe illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVaccine + PolyICLC

The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.

Locations(1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT01720836

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