Abstract
A previous trial of autologous GVAX® immunotherapy for lung cancer in NSCLC yielded successful product manufacturing in 81% of patients enrolled and demonstrated complete tumor responses in 3 of 33 advanced stage patients treated (Nemunaitis, JNCI 2004;96:326–31). A novel closed cell processing system was developed which shortens the process time to one day. We initiated a phase 2 trial with this modified manufacturing process in stage IIIB/IV NSCLC. Patients with successful product manufacturing were randomized to immunotherapy alone (every 2 wks × 5; cohort A) vs.
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