A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers
OBJECTIVES: I. Determine the safety of serial intradermal vaccinations of HER-2/neu derived
peptides with sargramostim (GM-CSF) as an adjuvant in patients with stage III or IV
HER-2/neu expressing breast, ovarian, or nonsmall cell lung cancer. II. Determine whether
immunity can be elicited with peptides derived from the intracellular domain of the
HER-2/neu protein. III. Determine whether immunity can be elicited with peptides derived
from the extracellular domain of the HER-2/neu protein. IV. Determine whether cytotoxic T
cells specific for the HER-2/neu protein can be elicited in patients with HLA-A2 by
immunization with peptides derived from the HER-2/neu protein.
OUTLINE: Patients receive one of three HER-2/neu peptide vaccine formulations that also
contain sargramostim (GM-CSF) as the vaccine adjuvant. Each vaccine is studied in 20
patients. A maximum of 3 patients receive a vaccine each month for 6 months to monitor the
potential toxicity associated with sequential immunizations. Patients receive a follow-up
evaluation 1 month after the last vaccination. Those patients who have an immune response
related to the vaccine will continue to have immunologic evaluations performed every 2
months while immune responses can still be detected.
PROJECTED ACCRUAL: 60 patients will be accrued.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mary (Nora) L. Disis, MD
University of Washington
United States: Federal Government
|University of Washington School of Medicine||Seattle, Washington 98195|