Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
- Determine the immunologic effects of adjuvant vaccine therapy comprising autologous
dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in
patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.
- Determine the potential clinical efficacy of this vaccine in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to type of prior
primary therapy (surgical vs nonsurgical).
Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the
production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung
cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine
intradermally once a month for 2 months in the absence of disease recurrence or unacceptable
Patients are followed monthly for 4 months, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study
within 3 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measurement of antigen specific reaction through six months post-vaccine
Edward Hirschowitz, MD
Lucille P. Markey Cancer Center at University of Kentucky
United States: Federal Government
|Markey Cancer Center at University of Kentucky Chandler Medical Center||Lexington, Kentucky 40536-0084|