Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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.
Biological: incomplete Freund's adjuvant
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Comparison of overall survival with historical controls [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
- 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.
|United States, Florida|
|Cancer Centers of Florida - Ocoee|
|Ocoee, Florida, United States, 34761|
|United States, New York|
|New York Oncology Hematology, P. C. at Albany Regional Cancer Care|
|Albany, New York, United States, 12208|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Dayton Oncology & Hematology, P.A. - Kettering|
|Kettering, Ohio, United States, 45409|
|United States, South Carolina|
|Cancer Centers of the Carolinas - Eastside|
|Greenville, South Carolina, United States, 29615|
|United States, Tennessee|
|Sarah Cannon Cancer Center at Centennial Medical Center|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Mary Crowley Medical Research Center at Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Tyler Cancer Center|
|Tyler, Texas, United States, 75702|
|United States, Washington|
|Cancer Care Northwest - North|
|Spokane, Washington, United States, 99218|
|Study Chair:||Scott Plasman||Epimmune|