RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES: Primary * Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only. * Determine the safety of this vaccine in these patients. Secondary * Determine progression-free survival of patients treated with this vaccine. * Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine. OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status. * Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15. * Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Cancer Centers of Florida - Ocoee
Ocoee, Florida, United States
New York Oncology Hematology, P. C. at Albany Regional Cancer Care
Albany, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comparison of overall survival with historical controls
Safety
Progression-free survival
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
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Dayton Oncology & Hematology, P.A. - Kettering
Kettering, Ohio, United States
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
Mary Crowley Medical Research Center at Sammons Cancer Center
Dallas, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Cancer Care Northwest - North
Spokane, Washington, United States