A Phase I Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers
OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of
HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres
with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing
cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein
can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine
which route of immunization, intradermal or subcutaneous, is more effective in generating
HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which
escalated dose of PLG peptide affects the immune response in these patients on this regimen.
OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients
are sequentially entered into one of three treatment arms: Arm I: Patients receive an
intradermal vaccination of HER-2 derived p369-377 peptide incorporated into
polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II:
Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated
into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of
subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG
microspheres with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in
the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) will be accrued for this
study.
Interventional
Primary Purpose: Treatment
Mary (Nora) L. Disis, MD
Study Chair
University of Washington
United States: Federal Government
CDR0000067339
NCT00005023
March 1999
January 2001
Name | Location |
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University of Washington School of Medicine | Seattle, Washington 98195 |