Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00104780
- Lead Sponsor
- Epimmune
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Comparison of overall survival with historical controls
- Secondary Outcome Measures
Name Time Method Progression-free survival Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
Trial Locations
- Locations (9)
New York Oncology Hematology, P. C. at Albany Regional Cancer Care
🇺🇸Albany, New York, United States
Mary Crowley Medical Research Center at Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Cancer Centers of Florida - Ocoee
🇺🇸Ocoee, Florida, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Dayton Oncology & Hematology, P.A. - Kettering
🇺🇸Kettering, Ohio, United States
Cancer Centers of the Carolinas - Eastside
🇺🇸Greenville, South Carolina, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Sarah Cannon Cancer Center at Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Cancer Care Northwest - North
🇺🇸Spokane, Washington, United States