Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00104780|
Recruitment Status : Unknown
Verified March 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 4, 2005
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: EP-2101 Biological: incomplete Freund's adjuvant||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2004|
- Comparison of overall survival with historical controls
- Progression-free survival
- Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104780
|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|