A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies
- Evaluate the immune response of patients with HER2/neu expressing advanced malignancies
showing no evidence of disease after standard treatment when injected with HER2/neu
intracellular domain protein pulsed autologous dendritic cells.
- Assess time to recurrence in these patients.
OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain
protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally,
followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with
keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also
receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment
continues every 3 weeks for a total of 4 courses in the absence of disease progression or
Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Michael A. Morse, MD
Duke Cancer Institute
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|