A Phase II, Open Label, Multi-Center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Comparison of overall survival with historical controls
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Sarah Cannon Cancer Center at Centennial Medical Center||Nashville, Tennessee 37203|
|Cancer Centers of the Carolinas - Eastside||Greenville, South Carolina 29601|
|Tyler Cancer Center||Tyler, Texas 75702|
|Mary Crowley Medical Research Center at Sammons Cancer Center||Dallas, Texas 75246|
|Cancer Care Northwest - North||Spokane, Washington 99218|
|Cancer Centers of Florida - Ocoee||Ocoee, Florida 34761|
|New York Oncology Hematology, P. C. at Albany Regional Cancer Care||Albany, New York 12208|
|Dayton Oncology & Hematology, P.A. - Kettering||Kettering, Ohio 45409|