Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Olivera Finn
Study ID
NCT01720836
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vaccine + PolyICLC — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2012
Status verified
Oct 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor
    Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
  • Experimental: Stage IB/II/IIIA
    Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
  • Experimental: Stage IIIA or IIIB
    Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.

Primary Outcome Measure

Immunologic response [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

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By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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