RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective immune response to kill non-small cell lung cancer cells. PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with first-line chemotherapy.
Overall Goals: \- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome. Primary Aim: \- to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC. Secondary Aims: * to study the immune response to vaccination, * to monitor clinical responses and * to recommend a dose-schedule combination for further testing in an initial Phase II trial of vaccine efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Dose Schedule 1 (DS-1): 4x10\^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10\^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10\^7 cells twice weekly, maximum 36 vaccines/patient
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Safety
Time frame: 6, 12, 18, 24, and 36 months post enrollment
Immunologic response: CD8, CD4 and NK response
Time frame: Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19
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