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)
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Comparison of overall survival with historical controls
No
Scott Plasman
Study Chair
Epimmune
United States: Federal Government
CDR0000415721
NCT00104780
December 2004
Name | Location |
---|---|
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 |